12.12 Single-Visit Surgery Offers Added Convenience and Excellent Family Satisfaction

Posted on January 18, 2018

C. A. Justus1, A. Milewicz1, M. Wortley1, F. Denner1, R. Bogle1, K. Ceyanes1, S. Shah1  1Texas Children’s Hospital,Pediatric General Surgery,Houston, TEXAS, USA

Introduction: The traditional model for elective ambulatory surgical care includes three separate visits to the surgeon: an initial consultation, a second for outpatient surgery, and a third for postoperative follow-up.  Single-Visit Surgery (SVS) is an alternative model of ambulatory surgical care that increases convenience to patients and their families by decreasing the burden of multiple visits.  SVS consolidates care into a single appointment where patients with straightforward surgical problems are evaluated in the morning and undergo a surgical procedure later that same afternoon.  In April 2016 SVS was introduced at a tertiary-care freestanding children’s hospital for the following conditions: umbilical hernia (over 3 years), inguinal hernia (over 12 months), hydrocele (over 12 months), and epigastric hernia.  Our objective for this study was to evaluate our early experience and conduct a survey of our patient’s caregivers to evaluate their satisfaction with SVS.

Methods: We retrospectively reviewed the medical records of patients that were seen as part of SVS from April 2016 through December 2016.  Data collected included demographics, diagnoses, procedures performed, and distance traveled to the hospital.  Additionally, adult caregivers of SVS patients were contacted and asked to participate in a telephone survey.  The telephone survey evaluated their satisfaction with SVS using a 5-point Likert scale.

Results: There were 43 patients seen through SVS during the study period, and 63% were male.  The median age was 7-years-old (IQR, 4.5 – 10).  The median roundtrip patient commute to the hospital was 30 miles (IQR, 23 – 64).  Of the 43 patients evaluated through SVS, 40 (93%) of them underwent surgery.  The most common procedure performed was inguinal hernia repair (n=20), followed by umbilical hernia repair (n=17), and epigastric hernia repair (n=1).  Of the 40 patients that had surgery, 27 (68%) of the families were contacted and participated in the telephone survey. Of those responding, 93% were strongly satisfied, and 7% were satisfied with the care through SVS. All families said they would recommend the SVS program to a friend.

Conclusion: Single-Visit Surgery is an alternative model of ambulatory surgical care that adds convenience to the patient experience and results in excellent family satisfaction. 

 

12.05 Engaging Families Through Shared Knowledge: RCT of Open Access to a Rapid Learning Healthcare System

Posted on January 18, 2018

D. O. Gonzalez1, Y. Sebastiao1, J. N. Cooper1, M. Levitt1, R. J. Wood1, K. J. Deans1  1Nationwide Children’s Hospital,Columbus, OH, USA

Introduction: A rapid learning healthcare system (RLHS) can deliver near-real time data to physicians and families about a disease and its outcomes based on specific patient characteristics. Giving families access to a RLHS may increase patient engagement, improve their knowledge, and lead to better outcomes. This study investigated the impact of allowing families of pediatric patients with complex colorectal diseases access to a RLHS on patient-centered outcomes. 

Methods:  We created a RLHS that integrates pre-specified data elements and validated surveys within the clinical workflow into the electronic health record. The RLHS is an interactive dashboard which contains information on a number of data points, including demographics, quality of life (QOL), surgical outcomes, complications, and continence. We performed a randomized trial of caregivers of children <18 years of age with an anorectal malformation, Hirschsprung disease, or functional constipation visiting our colorectal center. Prior to their initial office visit, participants were randomized to either standard surgical consultation or open access to the RLHS in addition to a standard consultation. To determine the effect of open access to the RLHS on patient-centered outcomes, we assessed healthcare satisfaction, quality of life (QOL), parent activation, health literacy, and caregiver knowledge about their child’s diagnosis. Outcomes between groups were compared at the end of the initial office visit and at 30 days. For participants randomized to the RLHS group, system usability was assessed and an exit interview conducted.

Results: Of 126 participants, 62 were randomized to the RLHS group and 64 were randomized to standard consultation. There were no differences in age, gender, or diagnosis between the patients and no differences in demographics between the caretakers in both groups. At the end of the initial clinic visit, there were no differences in healthcare satisfaction, QOL, parent activation, health literacy, and knowledge of disease between groups. After 30-day follow-up, there were no differences in healthcare satisfaction, QOL, and knowledge of disease. The usability and learnability of the RLHS were ranked 73.0 and 80.4, respectively, on a 100-point scale. Most participants reported that the RLHS included a lot of useful information and was easy to use. Approximately 25.0% of participants reported feeling overwhelmed when looking at the information on the RLHS, but only 3.6% reported that it increased their stress level. The majority of participants (83.9%) would recommend that we provide RLHS access to all families.

Conclusion: Although providing access to the RLHS did not affect patient-centered outcomes, the majority of patients recommended providing families access to this type of system. Although access to the information in the RLHS overwhelmed some of the patients, it did not affect the stress level of the vast a majority of patients.

12.06 Post-operative Complications in Children with Down Syndrome Correlate with Other Comorbidities

Posted on January 18, 2018

M. A. Bartz-Kurycki1,2, K. T. Anderson1,2, M. T. Austin1,2, L. S. Kao1, K. Tsao1,2, K. P. Lally1,2, A. L. Kawaguchi1,2  1McGovern Medical School, University Of Texas Health Sciences Center At Houston,Pediatric Surgery,Houston, TX, USA 2Children’s Memorial Hermann Hospital,Houston, TX, USA

Introduction:  Down syndrome (DS) is associated with multiple co-morbidities, which may increase the risk of post-operative complications. Physicians perceive that DS patients have a higher risk of post-operative complications; however, the literature remains unclear. This study evaluated the risk of post-surgical complications for abdominal and thoracic procedures in children with and without DS.

Methods:  The National Surgical Quality Improvement Program Pediatric (NSQIP-P) database was queried for patients under 18 years of age who underwent non-cardiac abdominal and thoracic operations (by CPT codes) between 2012 and 2016. Analysis compared patients based on the presence or absence of DS. The primary outcome was a composite of all post-operative complications as defined by NSQIP-P. Analysis utilized chi square, student’s t-test, and univariate and multivariate logistic regression. Potential pre-operative risk factors, including DS and those found in the NSQIP-P risk calculator, were evaluated for an association with post-operative complications. Variables were tested for interactions.

Results: 91,478 surgical patients were included with a mean age of 7.2 years ± 6.1 years. Of those patients, 57.8% were male and 1,476 (1.6%) had a diagnosis of DS. Baseline covariates demonstrated significant differences; patients with DS had higher rates of pre-operative nutritional support (38.8% vs. 15.0%), developmental delay (61.9% vs. 10.4%), and cardiac risk factors (76.5% vs 13.8%). The overall rate of post-operative complications was 10.9% and patients with DS demonstrated a higher proportion than controls (16.2% vs 10.8%, p<0.001). On univariate analysis, DS was associated with increased odds of post-operative complications (OR 1.6 95%CI 1.4-1.9) compared to the non-DS group; however, this risk was reversed when adjusting for all other covariates (aOR 0.86 95%CI 0.7-1.1; Table). Univariate analysis of individual surgical complications suggested an increased risk of sepsis (2.6 95%CI 1.8-3.6) and surgical site infection associated with DS (OR 1.6 95%CI 1.3-2.0) but were not statistically significant on multivariate analysis.

Conclusion: Although a greater proportion of post-operative complications were observed in patients with DS, when adjusting for other risk factors, DS was not an independent risk factor. The increased rate of complications is likely related to the presence of certain risk factors that are more common in DS, such as hematologic disorders, cardiac risk factors, nutritional supplementation, and ventilator dependence. Pre-operative counseling and optimization for patients with DS should be tailored to the individual based on their co-morbidities.

12.04 Nonoperative Anesthesia Time for Common Surgical Procedures in Young Children

Posted on January 18, 2018

K. Williams1, B. Nwomeh2, T. A. Oyetunji3  1Howard University College Of Medicine,General Surgery,Washington, DC, USA 2Nationwide Children’s Hospital,Columbus, OH, USA 3Children’s Mercy Hospital- University Of Missouri Kansas City,Kansas City, MO, USA

Introduction: Increasing attention is being paid to the neurotoxicity and potential long-term cognitive effects of general anesthesia (GA) in children younger than 3 years old. This study aims to describe the most common pediatric surgical procedures requiring GA in children less than 3 years, and the potential discordance in nonoperative anesthesia time  and operative anesthesia time.

Methods: The National Surgical Quality Improvement Program Pediatric (NSQIP-P) database for 2012-2013 was queried for all children 3 years old or less who underwent GA for an inpatient pediatric general surgical procedure. Demographic data, procedure by Current Procedural Terminology (CPT) code, case type, operating time, anesthesia time, and American Society of Anesthesiologists (ASA) class were descriptively analyzed. Those who underwent additional procedures during the same anesthesia period were excluded. For each procedure, the difference between total anesthesia time and total operating time was calculated, yielding the nonoperative anesthesia time.

Results: A total of 5143 patients were identified. Of these, 63% were male and 68% were White. The median age at admission was 64 days (IQR 28-294) and 78% were infants. Most cases were elective (59%), and the most common ASA class was 2 (38%). The most common procedures performed in children younger than 3 years were pyloromyotomy (21%), laparoscopic gastrostomy (8.6%), and unlisted procedures on the stomach (6.6%). The median nonoperative anesthesia times were 45 mins (IQR 37,55), 48 mins (IQR 37, 64), and 48 mins (IQR 38, 62) respectively. (Table 1)

Conclusion: For the most common procedures requiring GA in children less than 3 years, the median nonoperative anesthesia time exceeds operative anesthesia time by more than 45 minutes, suggesting that this is a potentially modifiable target for decreasing anesthetic exposure. The provider and systems level factors that contribute to this time discordance need to be explored.

 

12.03 Earlier Feeding after Congenital Diaphragmatic Hernia Repair Associated with Shorter Hospitalization

Posted on January 18, 2018

S. M. Deeney1, D. D. Bensard1, T. M. Crombleholme1  1Children’s Hospital Colorado,Department Of Pediatric Surgery,Aurora, CO, USA

Introduction:
The benefits of early enteral feeding have been demonstrated in expedited recovery after surgery protocols for various procedures such as adult colorectal surgery. Little is known regarding the effect of earlier enteral feeding in patients after congenital diaphragmatic hernia (CDH) repair.

Methods:
Retrospective patient data of all patients who underwent CDH repair from 2008 through 2015 was collected at our institution, excluding patients who died prior to initiation of enteral feeding (n=64). Statistical analysis was by Student’s t test, chi square, and Fisher’s exact test, p<0.05.

Results:
Patients who started enteral feeding 5 days or earlier following CDH repair had a statistically shorter length of hospitalization than those fed 6 days or later postoperatively (51±42 vs 85±125 days, p=0.03). There was no significant difference between groups in survival to discharge (95% vs 85%, p=0.3), ventilator time (24±44 vs 95±167 days, p=0.07), postoperative total infection rates (38% vs 45%, p=0.16) and wound complication rates (2% vs 15%, p=0.09).

Conclusion:
There is an association between earlier enteral feeding and decreased length of hospitalization in patients who have undergone CDH repair. All other factors studied did not reach statistical significance, possibly due to underpowering. These results need to be validated in a prospective randomized, controlled study.
 

12.01 Maintaining Oncologic Integrity with Minimally Invasive Resection of Pediatric Embryonal Tumors

Posted on January 18, 2018

H. M. Phelps1, G. D. Ayers2, J. M. Ndolo3, H. L. Dietrich4, K. D. Watson5, M. A. Hilmes3, H. N. Lovvorn6  1Vanderbilt University Medical Center,School Of Medicine,Nashville, TN, USA 2Vanderbilt University Medical Center,Division Of Cancer Biostatistics,Nashville, TN, USA 3Vanderbilt University Medical Center,Pediatric Radiology,Nashville, TN, USA 4Vanderbilt University Medical Center,School Of Nursing,Nashville, TN, USA 5Vanderbilt University Medical Center,Pediatric Hematology/Oncology,Nashville, TN, USA 6Vanderbilt University Medical Center,Pediatric Surgery,Nashville, TN, USA

Introduction:  Embryonal tumors arise typically in infants and young children and are often massive at presentation. Treatment is multimodal, and while complete resection is a critical element, surgery can interrupt therapy. When appropriate, minimally invasive surgery (MIS) offers a potential means to minimize treatment delays. However, the use of MIS to resect embryonal tumors remains controversial regarding the oncologic integrity of this approach.

Methods:  A retrospective review of embryonal tumors treated at a single institution over a 15-year period was conducted to: 1) assess candidacy of embryonal tumors for MIS, and 2) evaluate outcomes for patients undergoing MIS versus open resection. Query of the institution’s cancer registry identified pediatric patients treated for intracavitary embryonal tumors from 2002 to 2017. To assess amenability for MIS, tumor volume (TV) and image-defined risk factors (IDRF, neuroblastic tumors only) were measured radiographically at time of diagnosis and immediately before resection. Stage, Children’s Oncology Group risk stratification, procedure-related details, delay to next dose of chemotherapy, relapse-free survival (RFS), and overall survival (OS) were evaluated. Wilcoxon, Pearson chi-square, and log-rank tests were performed.

Results: A total of 201 patients were treated for neuroblastic tumors (NBL, n=101), Wilms tumor (WT, n=66), hepatoblastoma (n=23), rhabdomyosarcoma (RMS, n=10), and pancreatoblastoma (n=1). Among these patients, 175 tumors were resected either open (n=151, 86%) or by MIS (n=24, 14%; 20 NBL, 3 WT, 1 RMS). Of the 174 with complete data at time of analysis, the median TV at resection was 84.8 ml [IQR 20.4, 372.5]. For NBL cases, a significantly greater proportion of MIS resections (n=17, 94%) had no IDRF when compared to open resections (n=31, 48%; p<0.001). For the entire cohort, RFS at 5 years was 0.78 [CI 0.71–0.85] for open resection versus 0.90 [CI 0.78–1.00] for MIS (p=0.463). OS at 5 years was 0.87 [CI 0.81–0.93] for open resection versus 1.00 [CI 1.00–1.00] for MIS (p=0.294). The largest TV resected via MIS was 93.4 ml, so subgroup comparisons were adjusted for TV<100 ml. No significant difference in margin status between open resection (n=68) and MIS (n=23) was observed, and MIS was associated with significantly less blood loss, shorter hospital stays, shorter operating time, and quicker return to the next chemotherapy cycle (Table 1).

Conclusion: For appropriately selected patients, MIS resection of pediatric embryonal tumors, particularly NBL, maintains an acceptable oncologic integrity while minimizing treatment delays, but large tumor volume, vascular encasement, and small patient size limit its broader applicability.

12.02 Does Muscle Biopsy change the treatment of Pediatric muscular disease?

Posted on January 18, 2018

N. Le1, J. Sujka1, J. Sobrino1, L. A. Benedict1, R. Rentea1, H. Alemayehu1, T. Oyetunji1, S. St. Peter1  1Children’s Mercy Hospital- University Of Missouri Kansas City,Kansas City, MO, USA

Introduction:
Muscle disease presentation is highly variable. Tissue biopsy is performed to confirm diagnosis and to guide therapy however it is unclear if this changes management. The purpose of our study was to determine if muscle biopsy changed patient diagnosis or treatment, which patients were most likely to benefit from muscle biopsy, and the complications resulting from muscle biopsy.

Methods:

With IRB approval a retrospective chart review of all patients less than 18 years old undergoing muscle biopsy between Jan 2010 and Aug 2016 was performed.  Demographics, patient presentation, change in treatment and diagnosis, hospital course, and follow up were evaluated. T-test and descriptive statistical analysis was performed; all means reported with standard deviation.

Results:

A total of 90 patients underwent a muscle biopsy at our institution during the study period. Mean age at time of biopsy was 6.5 years (±5) with the most common site of biopsy was the vastus lateralis. Of these patients only 37% (n=34) had a definitive diagnosis by muscle biopsy, in the remaining patients 27% (n=25) were normal and 35% (n=31) were non diagnostic. Of all patients biopsied, 39% (n=35) had a change in their diagnosis with only 37% (n=34) having a change in their treatment course from the pathology result.

Among the 34 patients who had a change in their treatment, the most common diagnosis was Inflammatory muscle disease at 44% (n=15) followed by those with muscular dystrophy, 23% (n=8). In the 56 patients who did not have a change in treatment, the most common diagnosis was hypotonia at 30% (n=17) followed by those patients whose diagnosis remained undetermined at 25% (n=14). However, the third most common diagnosis that did not change treatment was inflammatory with 21% (n=12). Two of these patients had definitive diagnosis from their biopsy but the remaining 10 were previously suspected of, and being treated for, myositis.

Using the T-test we compared those who did or did not have a change in treatment based on their pathology. There was no statistically significant difference in the patient’s weight, age, operative duration, or length of follow up post operatively. One patient was found to have a complication from surgery, malignant hypothermia. No patients returned to the operating room secondary to operative complications. Mean length of follow up for all patients was 2.75 years (±2).

Conclusion:

Muscle biopsy could be considered to diagnose patients with symptoms consistent with inflammatory or dystrophic muscular disease though the likelihood of this altering the patient’s treatment course is less than 50%.

11.18 Pancreatic Neuroendocrine Tumor (PNET) Imaging Features are Predictive of Biology

Posted on January 18, 2018

A. Fang1, E. Tashakori1, C. Farinas1, M. Mederos1, A. McElhany1, S. Mohammed1, N. Villifane1, W. E. Fisher1, G. Van Buren1  1Baylor College Of Medicine,Michael E. DeBakey Department Of Surgery, The Elkins Pancreas Center,Houston, TX, USA

Introduction:
Pancreatic neuroendocrine tumors (PNETs) are a heterogeneous group of tumors with variable malignant potential. While most PNETs appear as solid, well-circumscribed, and enhancing masses on computed tomography (CT), their heterogeneous nature can lead to differences in their stereotypical appearance. Therefore, the objective of this study was to test the hypothesis that PNETs with atypical features on CT were associated with more aggressive pathologic features.

Methods:
Through our prospectively maintained Pancreas Surgery Registry, we retrospectively analyzed the radiologic and pathologic features of resected PNETs between January 2005 and December 2015. After independent verification, the CT characteristics such as size, morphology, and enhancement pattern were compared to their histopathologic findings using Chi square and Fisher’s exact tests. Multivariate logistic regression models were generated with backward selection method and a removal p value of 0.1. 

Results:
We analyzed 52 patients who underwent preoperative CT imaging and PNET resection. 29 lesions demonstrated abnormal imaging characteristics such as hypoenhancement (4), isoenhancement (1) calcifications (7), and cystic appearance (19). On univariate analysis, cystic appearance was significantly associated with lower grade and less lymphovascular invasion (p = 0.02, and 0.04, respectively). Bile duct dilation and lymphadenopathy were significantly associated with higher grade and stage, (p = 0.02 and 0.01, respectively). Tumor size significantly correlated with higher stage, positive margin, and lymphovascular invasion (p = 0.02, 0.03, and 0.02, respectively). On multivariate analysis, when controlling for lymphadenopathy, bile duct dilation, and image size, cystic lesions were a significant predictor of lower staging (p = 0.003, 0.01, and 0.01, respectively) and lower rates of lymphovascular invasion (p = 0.04). Hypoenhancment, isoenhancment, and calcifications did not correlate with aggressive pathologic findings.

Conclusion:

This cohort study demonstrated that PNETs with cystic appearance were less aggressive. Conversely, characteristics such as lymphadenopathy, bile duct dilation, and larger lesion size were predictors of aggressive pathologic characteristics. However, enhancement pattern and the presence of calcifications on CT were not associated with more aggressive features. 

11.19 Smoking and Next Generation Sequencing Mutation Signature in Melanoma

Posted on January 18, 2018

K. Loo1, I. Soliman1, M. Renzetti1, T. Li1, H. Wu1, B. Luo1, A. Olszanski1, S. Movva1, M. Lango1, N. Goel1, S. Reddy1, J. Farma1  1Fox Chase Cancer Center,Philadelphia, PA, USA

Introduction: The use of molecular profiling to characterize tumors is becoming increasingly utilized to guide and tailor therapies for personalized treatment in the setting of malignant melanoma. Furthermore, smoking has been identified as a largely preventable cause of cancer mortality. Yet it remains to be seen whether smoking has a causative or protective effect in the setting of malignant melanoma. Using Next Generation Sequencing (NGS), we investigated a panel of 50 targetable cancer-related gene mutations in melanoma tumors. The principle aim of this study was to investigate the correlations between previous history of smoking with genetic mutations among individual genes, as well as total mutation burden in patients with malignant melanoma.

Methods: A retrospective study was conducted to include both primary and recurrent malignant melanoma tumor samples. Utilizing a prospective database, we identified a cohort of patients whose tumor tissue samples underwent NGS sequencing analysis for somatic mutations of 50 cancer-related genes. Within this cohort, clinical and pathological data were also collected. A univariate analysis was conducted using Fisher’s exact and Wilcoxon tests to compare patients with previous history of smoking to never smokers to investigate differences in each cohort’s molecular profile.  

Results: A total of 173 patients with malignant melanoma whose tumor tissue specimens underwent NGS sequencing were analyzed in this study cohort. Median age at diagnosis was 65 (range 21-94) and 64% were male (n=111). The smoking cohort was divided into never smokers (n=72) versus current or former smokers (n=101). Of the 168 patients with staging data, 9% of patients were Stage I melanoma (n=15), 30% Stage II (n=50), 49% with Stage III (n=83), and 12%with Stage IV (n=20).

In the total cohort, 277 mutations were identified affecting 34 unique genes. No mutations were found in 12% of patients (n=20), while 47% of patients (n=82) had 1 mutation, 24% (n=41) had 2 mutations, 9% (n=16) had 3 mutations, and 8% (n=14) had 4 or more mutations. The most common mutations among patients with a history of smoking were BRAF v600E (27.7%, vs. 19.4% in never smokers) and CDKN2A (12.87%, vs. 9.72% in never smokers) genes. Conversely, the most common genes among never smokers were NRAS (34.72%, vs. 31.7% in smokers) and TP53 (22.22%, vs. 21.8% in smokers). The overall mutation burden in the never smoker cohort was 1.59 versus 1.60 in the current and former smoker cohort (p=0.94).

Conclusion: This study demonstrated no significant association of overall mutational burden or increased incidence of individual gene mutations to smoking status, additional studies are needed to identify the effect of smoking on melanoma tumor characteristics with a larger sample size. Further studies with additional tumor biomarkers are additionally warranted to discern the impact of smoking on malignant melanoma tumors. 

11.16 Perioperative Chemoradiation Does Not Influence Incisional Hernia Formation After Cancer Resection

Posted on January 18, 2018

S. Kavalukas1, R. Baucom2, L. Huang1, S. Phillips1, C. Bailey1, R. Pierce1, M. Holzman1, K. Sharp1, B. Poulose1  1Vanderbilt University Medical Center,Department Of Surgery,Nashville, TN, USA 2Baylor University Medical Center,Dallas, TX, USA

Introduction:  The effect of adjuvant therapy on subsequent ventral incisional hernia (VIH) formation after cancer resection is unknown.  This study assessed the impact of adjuvant therapy on long term VIH formation after tumor resection for abdominal malignancy.

Methods:  Patients undergoing resection of abdominal malignancy were retrospectively identified and followed up to 2 years by computed tomography (CT) scan for VIH formation.  Those who received either chemotherapy and/or radiation 6 months before or after resection (adjuvant therapy, AT) were compared to patients without adjuvant therapy (no adjuvant therapy, NAT).  Cox proportional hazards (CPH) regression was used identify factors associated with VIH formation over time while adjusting for multiple confounding factors.

Results: 485 patients underwent abdominal cancer resections (AT n=105; NAT n=380). The median age was 58 yrs for the AT group and 61 for the NAT group. 40% of the AT group and 41% of the NAT group were female. The clinical cancer stage breakdown was statistically significant between the 2 groups (AT had more stage 4 and NAT had more stage 1 cancers). The proportion of patients free of VIH at 24 months was 46% in the AT group and 39% in the NAT group (Figure, p=0.62).  AT was not found to be associated with increased VIH compared to NAT in the CPH model (HR=0.817, 95% CI: (0.567, 1,177).

Conclusion: The rate of incisional hernia formation after resection for abdominal malignancy does not appear to be influenced by adjuvant chemo- or radiotherapy. Continued evaluation of risk factors and the role of hernia prevention is important to maintain quality of life for cancer survivors. 

 

11.17 The Emerging Role of Surgery in Melanoma Patients Treated with Immune Checkpoint Inhibitors (ICI)

Posted on January 18, 2018

C. Puza1, P. Mosca1, A. K. Salama2, H. Howard3, D. Agnese3, A. Terando3, D. G. Blazer1, R. Scheri1, G. Beasley1  1Duke University,Department Of Surgery,Durham, NC, USA 2Duke University,Division Of Medical Oncology,Durham, NC, USA 3Ohio State University,Division Of Surgical Oncology,Columbus, OH, USA

Introduction: The emergence of novel ICI has resulted in dramatic improvements in survival for patients with metastatic melanoma. Relative to traditional chemotherapy, the types of disease response patterns to ICI therapy can be more complex, including mixed responses and pseudoprogression.  Specifically, some lesions may regress while new lesions appear, or tumors may remain stable in size for long periods of time. As the role of surgery in these scenarios is continuing to evolve, the purpose of this study was to explore outcomes associated with surgery following ICI therapy. 

Methods:  A retrospective study was conducted at two centers and included patients with melanoma who underwent surgery following treatment with monotherapy or combination therapy with anti-PD-1 and/or anti CTLA-4 checkpoint blockade.  Data collected included: treatment regimen, toxicities, operative reports, pathology, and clinical plus radiographic follow-up.

Results: Of 17 identified patients, 7 patients had received anti-CTLA-4 therapy, 4 anti-PD-1 therapy, and 6 anti-CTLA-4 therapy plus anti-PD-1 therapy before surgery. Five patients were being treated in the adjuvant setting and developed new lesions while 12 patients were being treated for metastatic disease and underwent surgery for persistent disease on imaging.   Seventeen patients underwent 18 operations including: 4 small bowel resections, 2 splenectomies, 4 wide local excisions, 4 groin dissections, 1 craniectomy, 1 mesenteric mass resection, 1 axillary dissection, and 1 lung nodule resection.  There were no major reported complications from surgery.  Seventeen of 18 masses were confirmed to be persistent melanoma on surgical pathology while 1 was a desmoid tumor.  At median follow up of 10-months, 1 patient has died, 8 are alive with known disease, and 8 continue to have no further evidence of disease since the time of surgery. 

Conclusion: In this small group of patients receiving ICI therapy for melanoma, surgery was well tolerated. Surgery may benefit select patients with mixed responses to ICI therapy. Indications for surgery in this population warrant further exploration.  

 

11.14 RAS Mutation Confers Prognostic Significance in Patients Undergoing CRS-HIPEC for Colorectal Cancer

Posted on January 18, 2018

Z. Morgan1, A. Krepline1, M. Hembrook1, S. Tsai1, K. K. Christians1, H. Mogal1, T. C. Gamblin1, C. N. Clarke1  1Medical College Of Wisconsin,Division Of Surgical Oncology,Milwaukee, WI, USA

Introduction: Approximately 5% of patients with colorectal cancer (CRC) will present with peritoneal carcinomatosis (PC) with a mean overall survival (OS) of 6-months if left untreated. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is an aggressive surgical approach to treat peritoneal carcinomatosis (PC).  The role of this procedure in CRC continues to evolve.  There remains a significant need to further characterize the natural history of CRC carcinomatosis and identify prognostic factors to facilitate better risk stratification for prospective CRS-HIPEC patients. We performed a single institution study of CRC patients undergoing CRS-HIPEC with curative intent to identify prognostic factors associated with recurrence or overall survival.

Methods: Patients with CRC evaluated for CRS-HIPEC at the Regional Therapies Program at the Medical College of Wisconsin from 2010 -2017 were identified. Patients with non-CRC pathology, progression of disease precluding surgical intervention and/or HIPEC for palliation were excluded.  Patients who had CRS only or did not receive at least 60 minutes of HIPEC were excluded. Clinicopathologic data including age, sex, PCI score, completeness of cytoreduction, lymphovascular invasion, neutrophil-lymphocyte ratio, histology, microsatellite stability, BRAF and RAS mutation status were collected and analyzed.

Results: 47 patients underwent CRS- HIPEC with curative intent. Median PCI score was 14 [IQR: 6-21]. 34 (72%) patients had complete (CC0) resection, 11(23%) had CC1 (≤0.25 cm residual tumor) resection, 2 (4%) had CC2 (0.25-2.5 cm) resection.  6 (13%) of CRC were MSI-high.  22 (47%) were RAS mutant, 4 (9%) BRAF mutant.  At median follow-up of 2 years, 23 (48%) died of disease with a median overall survival (OS) of 19 months [IQR: 10-27], 36 (77%) patients developed recurrence with a median disease free survival (DFS) of 7 months [IQR: 5-12].   No factors analyzed reached significance for OS. RAS mutation status and LVI were the only significant predictors of decreased DFS (p= 0.02 and 0.03 respectively) on univariate analysis. On multivariate analysis neither remained significant.  

Conclusion: CRS HIPEC can achieve improved survival in patient with PC from CRC, however better risk stratification is needed for patient selection.  RAS mutation status is an independent marker of poor prognosis and may provide enhanced prognostic information in these high risk patients.  Larger cohort studies are needed to validate these findings.

 

11.15 Impact of Marital Status on Presentation and Management of Early Stage Melanoma

Posted on January 18, 2018

C. E. Sharon1, A. J. Sinnamon1, M. E. Ming2, E. Y. Chu2, R. R. Kelz1, R. E. Roses1, D. L. Fraker1, G. C. Karakousis1  2Hospital Of The University Of Pennsylvania,Dermatology,Philadelphia, PA, USA 1Hospital Of The University Of Pennsylvania,Endocrine And Oncologic Surgery,Philadelphia, PA, USA

Introduction:
Early detection of melanoma is associated with improved patient outcomes. There is data to suggest that spouses or partners may facilitate detection of melanoma prior to the onset of regional and distant metastases. Less well known is the influence of marital status on the detection of early clinically localized melanoma. We sought to evaluate the impact of marital status on T stage at time of presentation for early stage disease and decision for SLN biopsy in appropriate patients.

Methods:
Patients at least 18 of age without evidence of regional or distant metastases were identified using Surveillance Epidemiology and End Results (SEER 2010-2014). The main independent variable of interest was marital status, categorized as married, never married, divorced, and widowed. Separate analysis dichotomizing patients as married or unmarried was also performed. Chi square test was used to evaluate for significant differences in distribution of T stage at presentation by marital status. Multivariable analysis using ordered logistic regression was performed to adjust for additional patient factors. 

Results:
A total of 56,718 patients were identified for study. Most patients were married (n=39,448, 70%). Others were never married (n=8,374, 15%), divorced (n=4,024, 7%), or widowed (n=4,872, 9%). Distribution of T stage at diagnosis was significantly different by marital status (p<0.001). Forty-three percent of married patients presented with T1a disease, compared to 40% of never married patients, 36% of divorced patients, and 30% of widowed patients (p<0.001). Conversely, 10% of widowed patients presented with T4b disease compared to only 4% of married patients (p<0.001). The association between marital status and higher T stage at presentation remained significant among all non-married groups after adjustment for income, age, gender, state of residence, urban versus rural, and high school education level. There was no observed effect modification between marital status and gender (p=0.17). Independent of T stage and other patient factors, never married and widowed patients were also less likely to undergo sentinel lymph node biopsy (SLNB) in lesions over 1mm in thickness, for which SLNB is routinely recommended (p<0.001).

Conclusion:
Married status is associated with earlier presentation of localized melanoma, which has important implications on prognosis and extent of surgery. Moreover, patients who are never married or widowed are less likely to undergo SLNB for lesions where it is routinely recommended. Marital status should be considered when counseling patients for melanoma procedures and when recommending frequency of screening and follow-up to optimize patient care. 
 

11.12 Fecal Diversion Is Rarely Necessary In Cytoreduction And Hyperthermic Intraperitoneal Chemotherapy

Posted on January 18, 2018

L. M. Cohen1, J. Baumgartner1, J. Veerapong1, A. Lowy1, K. J. Kelly1  1University Of California – San Diego,Surgical Oncology,San Diego, CA, USA

Introduction: There is currently no consensus on when stoma creation for temporary fecal diversion is indicated during cytoreduction and hyperthermic intrapertioneal chemotherapy (CRS/HIPEC). The aim of this study was to evaluate the indications for and outcomes following fecal diversion in CRS/HIPEC at a high volume center where stoma creation is used infrequently.

Methods:  A retrospective review of a prospectively maintained database of patients with peritoneal surface malignancy was performed to identify those who underwent complete CRS/HIPEC between 2007 and 2017.

Results: Of 416 patients who underwent complete CRS/HIPEC during the time period, 226 had at least one bowel resection and anastomosis and were included in the analysis. In total, 17 patients (8%) had a stoma created at the time of CRS/HIPEC. Six  (3%) had end colostomy and 11 (5%) had ileostomy meant for temporary fecal diversion. All patients with ileostomy creation underwent proctectomy. Additional factors associated with ileostomy creation included: Body mass index (BMI), prior systemic chemotherapy, operative time, and peritoneal carcinomatosis index (PCI) (Table). In all patients and in the subset that underwent low anterior resection (LAR) (n = 38), there were no differences in anastomotic leak rate (0% vs 3%, p=0.543), inpatient morbidity (64% vs 65%, p=0.945), or length of stay (median 11 days in both groups, p=0.926), but 60-day readmission rate was higher in patients with ileostomy (55% versus 25%, p=0.031). All patients with ileostomy underwent reversal. The median time to reversal was 98 days (range 62 to 567).

Conclusion: The main indication for diverting ileostomy in CRS/HIPEC was LAR. Diverting ileostomy was not associated with decreased anastomotic leak rate when considering all patients or the subset of patients that underwent LAR, but was associated with increased rates of 60-day readmission. These data suggest that the use of temporary fecal diversion in CRS/HIPEC is rarely required, including in patients who undergo LAR. 

 

11.09 Patient Characteristics and Outcomes among BRAF-mutated Colorectal Cancers: A Retrospective Review

Posted on January 18, 2018

J. Purchla1, W. H. Ward1, F. Lambreton1, N. Nweze1, T. Li2, N. Goel1, S. Reddy1, E. Sigurdson1, J. M. Farma1  1Fox Chase Cancer Center,Department Of Surgical Oncology,Philadelphia, PA, USA 2Fox Chase Cancer Center,Philadelphia, PA, USA

Introduction: Colorectal adenocarcinoma is a disease with varying causative molecular mechanisms, where chromosomal instability leads to gene specific mutations in proto-oncogenes and tumor suppressors. Among the most well-known mutations, the BRAF gene is associated with decreased disease-free and overall survival. This investigation strives to characterize patient and disease-related outcome measures among patients with BRAF-mutated colorectal adenocarcinoma.

Methods: A retrospective study was performed using molecular profiling (MP) data of 35 colorectal patients of any stage who were treated at our tertiary cancer center between 2006 and 2017. Those who did not undergo molecular profiling or those with incomplete data were excluded. If completed, additional genetic analyses performed within or external to our institution were also included. Demographic, clinical, and pathological data were collected and analyzed. Recurrence free survival was assessed using Kaplan-Meier estimation method.

Results: Out of 481 colorectal patients, 35 (7.3%) were identified as having a BRAF mutation. The median age at diagnosis was 73 years old (range 36-90), 25 (71%) were female, and 29 (82.9%) were white. There were 29 (82.9%) colon primary sites, 16 (55.2%) of those right-sided, and 6 (17.1%) rectal. 9 (25.7%) were stage IV, 15 (42.9%) were stage III, 7 (20.0%) were stage II, and 4 (11.4%) were stage I. A majority of patients (77.1%) exhibited more than just a BRAF mutation, with 15 (42.9%) positive for defective mismatch repair/microsatellite instability (dMMR/MSI), 10 (28.6%) with a P53 mutation, 4 (11.4%) SMAD4, 3 (8.6%) APC, and 3 (8.6%) PIK3CA. A total of 5 (14.3%) patients had a prior history of other cancer types. From this cohort, 29 (82.9%) had surgery, and 23 (79.3%) achieved an R0 resection. A total of 19 (54.3%) patients underwent adjuvant therapy. Targeted therapy with EGFR inhibitor was administered in 10 (28.6%) patients. Recurrence occurred in 10 (28.6%) patients, with the median time to recurrence 22.2 months. The recurrence free survival rate to 1 year was 74.5% and to 2 years was 37.1%. The overall survival rate to 1 year was 89.6%, and to 2 years was 56.8%.

Conclusions: In this cohort, patients with BRAF mutated colorectal cancer were generally older, white and female, and more likely to present with advanced disease. Of those who relapsed, more than 60% of patients did so within 2 years of diagnosis. Overall survival decreased substantially after 1 year. Tumors were primarily in the colon, specifically right-sided colon, with a MP likely to show more than 1 mutation. Our investigation shows that this cohort of BRAF-mutated tumors exhibits a poorer prognosis. To better characterize these patients and their disease-related outcomes, further investigation with a larger cohort is warranted. 

11.08 Neutrophil To Lymphocyte Ratio Predicts Outcomes After Chemoembolization for Neuroendocrine Tumors

Posted on January 18, 2018

S. M. McDermott1, N. Saunders3, E. M. Schneider2, D. Strosberg2, J. Onesti4, G. Davidson2, M. Bloomston5, M. Dillhoff2, C. R. Schmidt2, L. A. Shirley2  1Ohio State University,College Of Medicine,Columbus, OH, USA 2Ohio State University,Department Of Surgery,Columbus, OH, USA 3Emory University School Of Medicine,Department Of Surgery,Atlanta, GA, USA 4Mercy Health,Department Of Surgery,Grand Rapids, MI, USA 521st Century Oncology,Ft Myers, FL, USA

Introduction: The neutrophil to lymphocyte ratio (NLR) is predictive of outcomes in various cancers, including neuroendocrine tumors (NETs), as well as response to cancer related treatments, including transarterial chemoembolization (TACE). However, the role of NLR in patients with NET treated with TACE is incompletely understood. We hypothesized that, in patients with liver metastases from NETs, a lower NLR value pre-TACE, as well as post-procedure, would correlate with improved long-term outcomes.

Methods:

After IRB approval, we reviewed 262 patients who underwent TACE for metastatic NET at a single institution. NLR was calculated from the pre-TACE CBC drawn the day of the procedure and the post-TACE CBC drawn approximately one day, one week, and six months after initial treatment. NLR levels were then correlated with overall survival from the time of TACE.

Results:The median post-TACE survival of the entire cohort was 30.1 months. Mean NLR for patients who survived less than 3 years was 4.4 while the mean NLR for patients who survived more than 3 years was 3.3. Median overall survival of patients with a pre-TACE NLR < 4 was 33.3 months vs 21.1 months for patients with a pre-TACE NLR > 4 (p = 0.005). The median survival for patients with post-TACE NLR higher than pre-TACE NLR was 21.4 months vs 25.8 months for patients with post-TACE NLR less than or equal to pre-TACE NLR (p = 0.007) (Figure). NLR values from one day and one week post-TACE did not correlate with outcome.

Conclusion:

An elevated NLR pre-TACE, as well as an NLR value that has not returned to its pre-TACE value several months after the TACE, are associated with worse survival in patients with NET and liver metastases. This value can easily be calculated from the CBC routinely obtained from patients as part of their pre-procedural and post-procedural care. Calculating and trending NLR values for these patients may impact treatment strategies.

11.06 Timing of Radiation Improves Margin Status but Not Limb-Salvage Rates in Deep Extremity Sarcoma

Posted on January 18, 2018

R. D. Shelby1, L. Suarez-Kelly1, P. Y. Yu1, T. M. Hughes1, C. G. Ethun2, T. B. Tran3, G. Poultsides3, D. M. King7, M. Bedi7, T. C. Gamblin7, J. Tseng4, K. K. Roggin4, K. Chouliaras5, K. Votanopoulos5, B. A. Krasnick6, R. C. Fields6, R. E. Pollock1, J. H. Howard1, K. Cardona2, V. P. Grignol1  1Ohio State University,Columbus, OH, USA 2Emory University School Of Medicine,Atlanta, GA, USA 3Stanford University,Palo Alto, CA, USA 4University Of Chicago,Chicago, IL, USA 5Wake Forest University School Of Medicine,Winston-Salem, NC, USA 6Washington University,St. Louis, MO, USA 7Medical College Of Wisconsin,Milwaukee, WI, USA

Introduction:  The addition of radiation to surgery has improved limb-salvage rates for deep extremity sarcomas. Timing of delivery in a neo-adjuvant (NA) vs adjuvant strategy remains an area of study.  We sought to evaluate the effect of NA radiation on patients with deep extremity sarcomas from a multi-institutional database. 

Methods:  A retrospective review of all adult patients with deep extremity sarcomas who underwent surgical resection at 7 U.S institutions from 2000-2016 was performed. Categorical variables were compared using chi-square test. Continuous variables were compared using two-sample t-tests. To assess the impact of radiation on recurrence free survival (RFS) and overall survival (OS) Cox proportional hazard regression models were used. Multivariate analysis was performed for all statistically significant categories to evaluate association with OS and RFS. 

Results: 1483 patients with surgically resected deep extremity sarcomas were identified. Average tumor size was 15cm; the most common histology was undifferentiated pleomorphic sarcoma. 723 (50%) patients had surgery only, 419 (29%) had NA radiation and 311(21%) had adjuvant radiation. Most patients who received radiotherapy had grade 3 tumors (82% NA vs 81% adjuvant vs 60% surgery, p<0.0001). Patients receiving NA radiation were more likely to have a history of radiation (7% NA vs 2% adjuvant vs 4% surgery, p=.0060) and undergo core biopsy for diagnosis (67% NA vs 31% adjuvant vs 34% surgery, p<0.0001) than those who had surgery first. More patients in the NA and surgery alone group underwent radical resection (92% NA vs 83% surgery vs 78% adjuvant p<0.0001). The radiotherapy groups had significantly more limb-sparing operations (98% adjuvant vs 94% NA vs 87% surgery, p<0.0001). NA radiation increased post-operative complications (34% NA vs 24% surgery vs 16% adjuvant, p<0.0001) and the need for tissue flap reconstruction (38% NA vs 24% surgery vs 22% adjuvant, p<0.0001). NA radiotherapy led to more negative margins on frozen (87%% NA vs 79% surgery vs 72% adjuvant, p<.0001) and final pathology (90% NA vs 79% surgery vs 75% adjuvant, p<.0001). There were significantly fewer local recurrences in the NA group (14% vs 17% adjuvant vs 27% surgery, p=0.001). The surgery only group had the fewest metastatic recurrences (52% vs 72% NA vs 62% adjuvant, p=0.001). OS and RFS were better in the groups receiving radiation, although not statistically significant. On multivariate analysis there was no factor independently associated with survival. 

Conclusion: In this large multi-institutional study, radiotherapy (adjuvant and NA) improves limb salvage rates. NA radiation improves margin status and local recurrence rates, however with increased post-operative complications. There were no other differences related to timing of radiotherapy. Our findings are consistent with other smaller studies. 

11.01 Outcomes after CRS-HIPEC by Facility: Do Higher Volumes Matter?

Posted on January 18, 2018

K. N. Partain1, E. Gabriel1, K. Attwood2, C. Powers3, M. Kim3, S. P. Bagaria1, S. N. Hochwald3  1Mayo Clinic – Florida,Department Of Surgery, Section Of Surgical Oncology,Jacksonville, FL, USA 2Roswell Park Cancer Institute,Department Of Biostatistics,Buffalo, NY, USA 3Roswell Park Cancer Institute,Department Of Surgical Oncology,Buffalo, NY, USA

Introduction:  Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) offers favorable outcomes for select patients with appendiceal and colorectal cancer (CRC). Studies have suggested that this procedure should be performed at high-volume centers, which can limit access to treatment. The purpose of this study was to determine the association between treatment volume and outcomes for CRS-HIPEC.

Methods: This was a retrospective analysis using the National Cancer Data Base, 2004-2013. CRS-HIPEC treatment centers were stratified by low-volume (<10 cases/decade), middle-volume (11-20), and high-volume (>20). Patients who received any systemic chemotherapy were excluded. The primary, long-term outcome was overall survival (OS). Secondary, short-term outcomes included the number of lymph nodes examined in the surgical specimen, post-operative hospital length of stay (LOS), unplanned readmission rate, and 30- and 90-day mortality. 

Results: A total of 749 cases were identified: 303 at low-volume, 138 at middle-volume, and 308 at high-volume centers. Carcinomatosis of appendiceal origin was present in 84.5% of cases, with the remainder of CRC origin. Table 1 summarizes the baseline demographic and clinical characteristics among the three types of centers. Overall, the cases treated among different centers were similar with respect to age, race, insurance status, and comorbid status (as reported by the Charlson-Deyo comorbidity score). The average distance traveled was highly variable (low: 54.5 miles, middle: 238.3 miles, high: 364.1 miles; p<0.001). There was no difference in the average number of lymph nodes examined (low: 13.7, middle: 14.0, high: 12.4; p=0.33), readmission rates (low: 8.7%, middle: 8.9%, high 6.7%; p=0.87), 30-day morality (low: 0.9%, middle: 0.8%, high:1.8%; p=0.59), or 90-day mortality (low: 4.1%, middle: 3.4%, high:4.7%; p=0.83). There was a difference in the average hospital LOS (low: 13.9 days, middle: 17.3 days, high: 19.2 days; p=0.008). The median follow-up for OS was 48.3 months (range 0.5 – 101.8 months). There was no significant association between case volume and median OS (low: 45.8 months, middle: 58.4 months, high: 59.4 months; p=0.43).

Conclusion: Contrary to the push for centralization of CRS-HIPEC, this data suggests that CRS-HIPEC can be completed at lower volume performing centers to achieve similar short- and long-term outcomes compared to higher performing centers. Development of CRS-HIPEC programs in geographic areas of need may be beneficial for patients located far from centralized facilities.

11.02 History of Blistering Sunburn and Molecular Profile in Melanoma

Posted on January 18, 2018

I. Soliman1, N. Goel1, K. Loo1, M. Renzetti1, T. Li1, H. Wu1, B. Luo1, A. Olszanski1, S. Movva1, M. Lango1, S. Reddy1, J. Farma1  1Fox Chase Cancer Center,Philadelphia, PA, USA

Introduction:  Next Generation Sequencing (NGS) has opened the door to investigating the underlying genetic components of cancer, in the hopes of improving diagnostic and treatment efforts. At our institution, NGS is used to detect specific mutations from a targeted cancer panel of 50 genes. The objective of this study is to analyze the molecular profiles of patients with malignant melanoma (MM) and correlate specific gene mutations and mutation burden in patients with and without a history of blistering sunburn.

Methods:  Patients with melanoma of all stages who were asked about their history of blistering sunburn (yes/no) were included in the study. Using NGS, mutations were identified in targeted regions of 50 cancer-related genes. Clinical and pathologic data were collected retrospectively and evaluated using Fisher’s exact and Wilcoxon tests.

Results: The analytic cohort consisted of 91 patients with MM, 1 excluded from analysis due to insufficient DNA. Median age at diagnosis was 63 (range 21-89) and 66% were male (n=60).  66% of the patients had a history of blistering sunburn (n=60), while 34% did not have a history of blistering sunburn (n=31). Of the 89 patients with staging data, 8% were stage I (n=7), 30% were stage II (n=27), 58% were stage III (n=52), and 3% were stage IV (n=3). A total of 136 mutations were identified, affecting 29 unique genes. The most common mutation in patients with a history of blistering sunburn was NRAS (45%), while the most common mutation in patients without a history of blistering sunburn was BRAF V600E (32%). Patients with a history of blistering sunburn had an overall mutation burden of 1.7, compared to patients without a history of blistering sunburn who had an overall mutation burden of 1.2 (p=0.028). 

Conclusion: Using our NGS platform, we identified the most prevalent mutations and the overall mutation burden in melanoma patients with and without a history of blistering sunburn. There is a statistically significant association between overall mutation burden and a history of blistering sunburn. Additionally, the study revealed that the most common mutation in patients with blistering sunburn was NRAS, compared to BRAF V600E in those without a history of blistering sunburn. These findings motivate further investigation with a larger sample size and may provide prognostic value.
 

10.05 Establishing a context-appropriate trauma registry for Uganda using the local providers' perspective

Posted on January 18, 2018

J. A. Igu1, C. Haasbroek1, O. C. Nwanna-Nzewunwa1, I. Feldhaus1, M. Carvalho1, M. M. Ajiko2, F. Kirya2, J. Epodoi2, R. Dicker1, C. Juillard1  2Soroti Regional Referral Hospital,Department Of Surgery,Soroti, , Uganda 1University Of California – San Francisco,Center For Global Surgical Studies,San Francisco, CA, USA

Introduction:  

Trauma registries (TR) are key components of primary trauma data collection in developing countries. TR implementation can fail if stakeholder involvement is not prioritized. Stakeholder input, is required to create a context-appropriate TR that aptly captures trauma in developing countries. We sought to identify the key components of a context-appropriate prospective TR in a Ugandan Regional Referral Hospital and elicit the determinants of success and sustainability in implementing such a TR.

Methods:

Focus group discussions were held with all cadres of clinicians involved in trauma care delivery at the hospital to identify context-appropriate TR variables. These results informed the design of a TR, which was then implemented. After a one-week pilot of the TR form, we obtained providers’ views on the utility of the TR form by generating a satisfaction score (the average score derived from a five-point Likert scale) for each question.

Results:

Five focus groups consisting of 14 providers (4 intern doctors, 3 Ear-Nose-Throat care providers, 3 general surgeons, 2 orthopedic officers and 2 eye care providers) identified 47 context-appropriate TR variables. Variable categories included: demographics, history and physical exam, injury characteristics, prehospital care, prehospital transportation, investigations, interventions, diagnosis, outcome/discharge status, and consent. These providers listed five barriers to TR implementation: the perception that TRs are time-consuming and increase workload, difficulties following-up admitted patients, lack of personnel, lack of equipment and other resources to gather data, and participation and cooperation issues. They also cited the availability of TR forms distinct from patient forms, TR forms at the point of care, a TR point person, a local TR committee, a good file storage system, and provider TR awareness as facilitators of TR implementation. Providers identified lack of finances, motivation, and salary incentive, and loss of momentum of the TR project as barriers to sustainability. They named the creation and proper training of a local TR team, periodic project evaluation, efficient project resource allocation, creating a research culture, and foreign partnership(s) as facilitators of sustainability. The post-pilot survey captured the perceptions (Figure) of 29 providers (intern doctors, surgeons, clinical officers, nurses) who implemented the TR. Providers were mostly satisfied with the TR form and its implementation.

Conclusion:

Local providers’ perspectives are key to creating context-appropriate and sustainable TRs developing countries, and TR user satisfaction. Having dedicated resources, well-trained local TR staff, and local ownership of the TR is central to TR success.

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