Evaluation of long-term performance of an intraperitoneal biomaterial in the treatment of ventral hernias.

BACKGROUND: One-year device safety and clinical outcomes of ventral hernia repair with the GORE® SYNECOR Intraperitoneal Biomaterial, a hybrid composite mesh was evaluated. METHODS: This retrospective, multicenter, case review analyzed device/procedure endpoints and patient-reported outcomes in patients treated for hernia repair ≥ 1 year from study enrollment. RESULTS: Included were 459 patients (with 469 ventral hernias) with a mean age of 58 ± 15 years; 77.1% met Ventral Hernia Working Group 2 (VHWG2) classification. Mean hernia size was 18.9 cm2 and 57.3% of hernias were incisional. Laparoscopic or robotic approach was utilized in 95.4% of patients. Mesh location was intraperitoneal for 75.6% and bridging repair was performed in 57.3%. Procedure-related adverse events within 30-days occurred in 5.0% of patients and included surgical site infection (SSI), surgical site occurrence (SSO), ileus, readmission, and re-operation. Procedure-related SSI or SSO events were 3.8% through 12 months. SSO events requiring procedural intervention (SSOPI) were 2.6% through 24 months. Four patients (0.9%) had confirmed hernia recurrence through the study (the mean follow-up was 32-months, range 14-53 months). Subgroup comparisons were conducted for all type recurrence; only diabetes was found to be statistically significant (p = .0506). CONCLUSION: In this analysis, ventral hernia repair with hybrid, composite mesh results in successful outcomes in most patients. This study represents a heterogeneous patient population undergoing repair using various approaches, mesh fixation, and mesh placement locations. These data appear to confirm long-term acceptable safety and device performance with a low rate of recurrence in a predominantly VHWG2 population.

Subjective vs. objective assessment of simulation performance on laparoscopic cholecystectomy: are we evaluating the right things?

BACKGROUND: Simulation using virtual reality (VR) simulators is an important tool in surgical training. VR laparoscopic simulators can provide immediate objective performance assessment without observer evaluation. This study aims to explore the correlation between subjective observer evaluation and VR laparoscopic simulator performance metrics in a laparoscopic cholecystectomy (LC) simulation module. METHODS: A LC simulation module using a VR laparoscopic simulator was completed by PGY2-3 general surgery residents at a single institution. Simulation performance was recorded and evaluated by a trained evaluator using the validated Global Operative Assessment of Laparoscopic Skills (GOALS) form, the Objective Structured Assessment of Technical Skills (OSATS) form, and a LC-specific simulation assessment form (LC-SIM). Objective performance metrics were also obtained from the simulator system. Performance before the curriculum (pre-test) and after the curriculum (post-test) were compared. RESULTS: Fourteen residents were included in the study. There were significant improvements from pre-test to post-test on each component of GOALS, OSATS, and LC-SIM scores (all p values < 0.05). In terms of objective simulator metrics, significant improvements were noted in time to extract gallbladder (481 ± 221 vs 909 ± 366 min, p = 0.019), total number of movements (475 ± 264 vs 839 ± 324 min, p = 0.012), and total path length (955 ± 475 vs 1775 ± 632 cm, p = 0.012) from pre-test to post-test. While number of movements and total path lengths of both hands decreased, speed of right instrument also decreased from 4.1 + 2.7 to 3.0 ± 0.7 cm/sec (p = 0.007). Average speed of left instrument was associated with respect for tissue (r = 0.60, p < 0.05) and depth perception (r = 0.68, p < 0.05) on post-test evaluations. CONCLUSION: Our study demonstrated significant improvement in technical skills based on subjective evaluator assessment as well as objective simulator metrics after simulation. The few correlations identified between the subjective evaluator and the objective simulator assessments suggest the two evaluation modalities were measuring different aspects of the technical skills and should both be considered in the evaluation process.

A modular simulation curriculum to teach endoscopic stenting to practicing surgeons: an "Into the fire" approach.

BACKGROUND: Flexible endoscopy is a valuable tool for the gastrointestinal (GI) surgeon, creating a need for effective and efficient training curricula in therapeutic endoscopic techniques for trainees and practicing providers. Here, we present a simulation-based modular curriculum using an "into the fire" approach with hands-on pre- and post-testing to teach endoscopic stenting to practicing surgeons. METHODS: Three advanced flexible endoscopy courses were taught by expert surgical endoscopists from 2018 to 2019. The stenting module involved using self-expandable metal stents to manage simulated esophageal and gastroduodenal strictures on a non-tissue GI model. Based on the educational theories of inquiry-based learning, the simulation curriculum was designed with a series of pre-tests, didactics, mentored hands-on instructions, and post-tests. Assessments included a confidence survey, knowledge-based written test, and evaluation form specific to the hands-on performance of endoscopic stenting. RESULTS: Twenty-eight practicing surgeons with varying endoscopic experiences participated in the course. Most of the participants (67.9%) had completed over 100 upper endoscopic procedures and 57.1% were certified in Fundamentals of Endoscopic Surgery. After completing the modular curriculum, participant confidence survey scores improved from 11.4 ± 4.2 to 20.7 ± 4.0 (p < 0.001). Knowledge-based written test scores also improved from 7.1 ± 1.2 to 8.4 ± 0.9 (p < 0.001). In terms of technical performance, overall hands-on performance scores improved from 21.3 ± 2.7 to 28.9 ± 1.2 (p < 0.001) with significant improvement in each individual component of the assessment (all p values < 0.01) and the greatest improvement seen in equipment handling (88%) and flow of procedure (54%). CONCLUSION: Our modular simulation curriculum using an "into the fire" approach to teach endoscopic stenting is effective in improving learner knowledge, confidence, and hands-on performance of endoscopic stenting. This approach to simulation is effective, efficient, and adaptable to teaching practicing surgeons with varying levels of experience.

Inguinal hernia mesh is safe in 1720 patients.

BACKGROUND: There is substantial media and patient interest in the safety of mesh for hernia repair. However, there is a lack of data regarding health-related quality of life (HRQOL) outcomes in patients who undergo inguinal hernia repair (IHR) with mesh. The purpose of this study is report short and long-term postoperative quality of life outcomes in patients following IHR with mesh. METHODS: We analyzed outcomes of 1720 patients who underwent IHR with mesh between 2008 and 2019 at a single institution from a prospectively maintained quality database. All surgeries were performed by four board-certified surgeons. HRQOL outcomes were measured using the Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS) surveys that were administered preoperatively, 3 weeks, 6 months, 1, 2, and 5 years postoperatively. Survey responses were summarized as mean with standard deviation or frequency with percentage. Postoperative SOMS scores were compared to preoperative scores using the two-tailed paired t test with a significance level of p < 0.05. RESULTS: One (0.1%) patient experienced a mesh infection postoperatively. In terms of complications, 159 (9.2%) developed a seroma, 31 (1.8%) a hematoma, and 36 (2.1%) patients experienced a recurrence. SOMS Pain Impact, SOMS Pain Quality, and SOMS Pain visual analog scale at 3 weeks, 6 months, 1 year, 2 years, and 5 years were all improved from preoperative (all p < 0.05). At 5 years postoperatively, only 3.9%, 3.2%, and 3.1% of patients reported severe or disabling sensation of mesh, pain, and movement limitations, respectively. CONCLUSION: Inguinal hernia repair with mesh results in a low rate of complications. A minority of patients had severe or disabling symptoms at 5-year follow-up and generally reported improvements in pain impact and quality in long-term follow-up.

Crural closure, not fundoplication, results in a significant decrease in lower esophageal sphincter distensibility.

INTRODUCTION: The esophagogastric junction (EGJ) is a complex anti-reflux barrier whose integrity relies on both the intrinsic lower esophageal sphincter (LES) and extrinsic crural diaphragm. During hiatal hernia repair, it is unclear whether the crural closure or the fundoplication is more important to restore the anti-reflux barrier. The objective of this study is to analyze changes in LES minimum diameter (Dmin) and distensibility index (DI) using the endoluminal functional lumen imaging probe (FLIP) during hiatal hernia repair. METHODS: Following implementation of a standardized operative FLIP protocol, all data were collected prospectively and entered into a quality database. This data were reviewed retrospectively for all patients undergoing hiatal hernia repair. FLIP measurements were collected prior to hernia dissection, after hernia reduction, after cruroplasty, and after fundoplication. Additionally, subjective assessment of the tightness of crural closure was rated by the primary surgeon on a scale of 1 to 5, 1 being the loosest and 5 being the tightest. RESULTS: Between August 2018 and February 2020, 97 hiatal hernia repairs were performed by a single surgeon. FLIP measurements collected using a 40-mL volume fill without pneumoperitoneum demonstrated a significant decrease in LES Dmin (13.84 ± 2.59 to 10.27 ± 2.09) and DI (6.81 ± 3.03 to 2.85 ± 1.23 mm2/mmHg) after crural closure (both p < 0.0001). Following fundoplication, there was a small, but also statistically significant, increase in both Dmin and DI (both p < 0.0001). Additionally, subjective assessment of crural tightness after cruroplasty correlated well with DI (r = - 0.466, p < 0.001) and all patients with a crural tightness rating ≥ 4.5 (N = 13) had a DI < 2.0 mm2/mmHg. CONCLUSION: Cruroplasty results in a significant decrease in LES distensibility and may be more important than fundoplication in restoring EGJ competency. Additionally, subjective estimation of crural tightness correlates well with objective FLIP evaluation, suggesting surgeon assessment of cruroplasty is reliable.

Patient-reported bowel and bladder function is not adversely impacted by bariatric surgery.

INTRODUCTION: This study aims to assess the effect of bariatric surgery on patient-reported outcomes of bowel and bladder function. We hypothesized that bariatric surgery does not worsen bowel and bladder function. METHODS AND PROCEDURES: A retrospective review was conducted of a prospectively maintained surgical quality database. We included patients who underwent primary bariatric surgery at a single institution between 2012 and 2020, excluding revisional procedures. Patient-reported outcomes were assessed using Surgical Outcomes Measurement System (SOMS) bowel and bladder function questionnaires at time of pre-operative consult and routine post-operative follow-up visits through 2 years. Data were analyzed using a statistical mixed effects model. RESULTS: 573 patients (80.6% female) were identified with completed SOMS questionnaire data on bowel and bladder function. Of these, 370 (64.6%) underwent gastric bypass, 190 (33.2%) underwent sleeve gastrectomy, and 13 (2.3%) underwent either gastric banding or duodenal switch. Compared to pre-operative baseline scores, patients reported a transient worsening of bowel function at 2-weeks post-op (p = 0.009). However, by 3-months post-op, bowel function improved and was significantly better than baseline (p = 0.006); this improvement was sustained at every point through 2-year follow-up (p = 0.026). Bladder function scores improved immediately at 2-weeks post-op (p = 0.026) and showed sustained improvement through 1-year follow-up. On subgroup analysis, sleeve patients showed greater improvement in bowel function than bypass patients at 1-year (p = 0.031). Multivariable analysis showed significant improvement in bowel function associated with greater total body weight loss (TBWL) (p = 0.002). CONCLUSIONS: Bariatric surgery does not worsen patient-reported bowel or bladder function. In fact, there is overall improvement from pre-operative scores for both bowel and bladder function by 3-months post-op which is sustained through 2-year and 1-year follow-up, respectively. Most encouragingly, a greater TBWL is significantly associated with improved bowel function after bariatric surgery.

Teaching EndoFLIP Impedance Planimetry to Practicing Endoscopists: An "Into the Fire" Approach to Simulation.

Background. There are growing interests from practicing endoscopists to implement the functional lumen imaging probe (FLIP) impedance planimetry system. We present a simulation-based curriculum using an "into the fire" approach with hands-on pre- and post-tests to teach the use of this technology. Methods. The curriculum consists of a series of pre-tests, didactic content, mentored hands-on instructions, and post-tests. Pre- and post-testing included a knowledge-based written test, a confidence survey, and an assessment form specific to the hands-on performance of FLIP. Result. Twenty-two practicing physicians completed the curriculum. After course completion, participants had improved knowledge-based written test scores from 6.8±1.7 to 8.9±0.9 (P<0.001), confidence scores from 10.0±5.9 to 22.1±2.6 (P<0.001), and hands-on performance score from 11.4±3.4 to 23.1±2.0 (P<0.001) with significant improvement in all components of the hands-on skills. Conclusion. Our simulation curriculum is effective in improving confidence, knowledge, and technical proficiency when teaching the use of FLIP to practicing physicians.

Anti-reflux mucosectomy (ARMS) results in improved recovery and similar reflux quality of life outcomes compared to laparoscopic Nissen fundoplication.

BACKGROUND: Anti-reflux mucosectomy (ARMS) is a new endoscopic procedure involving a hemi-circumferential endoscopic mucosal resection (EMR) around the gastroesophageal junction. We aim to compare perioperative and quality of life outcomes of patients with reflux who underwent ARMS to a comparable group who underwent laparoscopic Nissen fundoplication (NF). METHODS: A retrospective review of a prospectively maintained quality database was performed. All patients who underwent ARMS (n = 33) were matched with patients who underwent NF (n = 67). Clinical and quality of life (QOL) outcomes were collected preoperatively and up to two years postoperatively, measured by the Reflux Symptom Index (RSI), Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), and Dysphagia Score. Outcomes were compared using the Wilcoxon rank-sum and Fisher's exact test. RESULTS: While 10 patients (30.3%) who underwent ARMS required additional laparoscopic anti-reflux operations, the ARMS group had shorter OR time (p<0.001), less estimated blood loss (p<0.001), shorter hospital stay (p<0.001), less pain at discharge (p = 0.007), earlier narcotic discontinuation (p<0.001), and earlier return to activities of daily living (p<0.001) compared to the NF group. There was no difference in 30-day complication rates, emergency room visits, or readmission rates between the groups. There was no difference between ARMS and NF groups in terms of GERD-HRQL, RSI, or Dysphagia scores at 3 weeks, 6 months, 1 year, or 2 years postoperatively. However, the ARMS group reported less symptoms of gas and bloating postoperatively at all time points (all p<0.05). Both groups reported increased dysphagia at 3 weeks postoperatively (p<0.01) but this did not persist at 6 months, 1 year, or 2 years. CONCLUSION: While ARMS had better perioperative outcomes compared to NF, reflux quality of life outcomes were comparable. ARMS can be an effective endoscopic intervention for GERD when performed on appropriately selected patients without limiting future laparoscopic anti-reflux interventions.

Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility.

INTRODUCTION: The Endoluminal Functional Lumen Imaging Probe (Endoflip) can be used to provide objective measurements of the gastroesophageal junction during fundoplication, and recent publications have suggested that this device could improve surgical outcomes. However, the impact of operative variables has not been clearly reported. The aim of this study is to determine the effect of these variables on functional lumen imaging probe (FLIP) measurements. METHODS: Following implementation of a standardized operative FLIP protocol, all data were collected prospectively and entered into a quality database. This database was queried for patients undergoing hiatal hernia repair and fundoplication. The protocol utilized various balloon volumes (30 and 40 ml), patient positions (flat and reverse Trendelenburg) and amounts of insufflation (15 mmHg pneumoperitoneum and no pneumoperitoneum). RESULTS: Between August 2018 and February 2020, 97 fundoplications were performed by a single surgeon. Multivariable analysis without interactions demonstrated that a 40 ml volume fill resulted in significantly higher minimum diameter (Dmin), cross-sectional area (CSA), intra-balloon pressure (IBP) and distensibility index (DI) compared to a 30 ml volume fill (p < 0.001). While reverse Trendelenburg positioning resulted in a significantly higher Dmin, IBP and CSA compared to the flat position (all p < 0.05), there was little impact of positioning on DI. Lastly, pneumoperitoneum significantly increased IBP (p < 0.001) but did not affect Dmin (p = 0.697) or CSA (p = 0.757), which resulted in a significant decrease in DI (p < 0.001) when compared to measurements without pneumoperitoneum. Multivariable analysis allowing for interactions demonstrated significant two-way interactions between balloon volume and pneumoperitoneum (p = 0.047), as well as patient position and pneumoperitoneum (p < 0.001). CONCLUSION: Surgeons should consider balloon volume and the presence or absence of pneumoperitoneum when interpreting distensibility during or after fundoplication. Additionally, we suggest a formal standardized protocol for FLIP measurements to utilize a 40 ml volume fill in reverse Trendelenburg without pneumoperitoneum.

Effects of dexamethasone on postoperative urinary retention after laparoscopic inguinal hernia repair.

BACKGROUND: Postoperative urinary retention (POUR) is a complication of laparoscopic inguinal hernia repair (LIHR). Previous research has identified predictive factors of POUR, such as age and history of benign prostatic hyperplasia (BPH). There is currently limited work on preventative measures. We hypothesize dexamethasone, a steroid, reduces POUR rates following LIHR due to its mechanism. METHODS: Consecutive patients (n = 979) undergoing LIHR from 2009 to 2017 at a single institution were selected from a prospectively managed database. All procedures were performed by four general surgeons. Only male patients were selected, as the majority of POUR occurs in males. Patients were retroactively chart reviewed and divided into two groups, dexamethasone use (n = 623) and no dexamethasone use (n = 356). Perioperative factors were compared between groups with Chi-square and independent samples t tests. Univariable and multivariable logistic regression analysis was used to assess whether dexamethasone use was associated with POUR. A subgroup analysis was performed on the dexamethasone group to determine any dose-dependent effects. RESULTS: We found a significant difference in POUR between the dexamethasone group and no dexamethasone group (3.7% vs. 9.8%, p = 0.0001). Patients in the dexamethasone group had a shorter length of stay, and were less likely to have BPH or a Foley placed (all p < 0.05). Age and BMI were similar between groups. Multivariable analysis showed that the use of dexamethasone was associated with a reduced risk of POUR (OR 0.52, 95% CI 0.2-0.97, p = 0.0386), while controlling for factors such as age and BPH. A subgroup analysis examined the effect of dexamethasone per unit (mg) increase. There was no significant association between dexamethasone dose and POUR rates (OR 1.07, 95% CI 0.82-1.38, p = 0.6241). CONCLUSIONS: Patients who received dexamethasone showed a lower rate of POUR regardless of dose. These results suggest dexamethasone can be administered to reduce POUR in males undergoing LIHR.

An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair.

BACKGROUND: It remains unclear whether use of self-fixating mesh during laparoscopic inguinal hernia repair (LIHR) impacts postoperative quality of life (QoL). We hypothesize patients receiving self-fixating mesh during totally extraperitoneal (TEP) LIHR will report less pain and improved QoL compared to those receiving non-fixating mesh. METHODS: An IRB-approved, single-blinded randomized controlled trial was conducted. Patients with primary, unilateral inguinal hernias were randomized to receive either non-fixating (control) or self-fixating mesh. Clinical visits were conducted 3 weeks and 1 year after LIHR. A validated Surgical Outcomes Measurement System (SOMS) instrument was used to assess patients' QoL preoperatively and postoperatively along with Carolinas Comfort Scale (CCS) at 3 weeks and 1 year after surgery. Comparisons between self-fixating and non-fixating mesh groups were made using Chi-square, Wilcoxon rank-sum or independent samples t tests. RESULTS: Two hundred and seventy patients were enrolled (137 non-fixating vs 133 self-fixating). Preoperatively, there was no difference in mean age, BMI, or median hernia duration between groups (57.9 vs 56.6 years, p = 0.550; 26.1 vs 26.8, p = 0.534; 3.0 vs 3.0 months, p = 0.846). Median operative times (34 vs 34 min, p = 0.545) and LOS were similar. More patients in the non-fixating group received tacks (43 vs 19, p = 0.001). Patients receiving non-fixating mesh recorded better mean SOMS scores for the first 3 days following surgery (Day 1: p = 0.005; Day 2: p = 0.002; Day 3: p = 0.024, Table 1) indicating less pain. No differences in pain were seen 3 weeks or 1 year postoperatively. There were zero recurrences found during clinical follow-up in either of the groups. CONCLUSIONS: Patients receiving self-fixating mesh report worse postoperative pain in the first 2-3 days than those receiving non-fixating mesh. The groups showed no differences across QoL metrics (SOMS and CCS) at 3 weeks or 1 year postoperatively. Self-fixating mesh does not appear to positively impact QoL after TEP LIHR.

Predicting Progression in Barrett's Esophagus: Development and Validation of the Barrett's Esophagus Assessment of Risk Score (BEAR Score).

OBJECTIVE: To develop and validate a scoring tool capable of accurately predicting which patients with Barrett's esophagus (BE) will progress to dysplasia and/or esophageal adenocarcinoma. BACKGROUND: Endoscopic therapies have emerged capable of eradicating BE with high efficacy and low complication rates, but which patients should receive treatment is still debated. Current knowledge of risk factors is insufficient to allow for the accurate prediction of which patients will progress to dysplasia or adenocarcinoma. METHODS: We retrospectively collected data from a cohort of BE patients over a 13-year period. A multivariable logistic regression model was constructed to predict progression. A simplified risk of progression (ROP) score was developed from weighted beta coefficients. Internal validation was performed using bootstrap analysis, and model discrimination was assessed using k-fold cross-validation. RESULTS: The cohort included 2591 BE patients of which 133 progressed to dysplasia/adenocarcinoma. Multivariable analysis with bootstrap internal validation resulted in 5 variables associated with an increased ROP (age ≥70 years, male sex, lack of proton-pump inhibitor use, segment greater than 3 cm, and history of esophageal candidiasis). Using this model, we developed a simple ROP score between 0 and 8. Receiver operating characteristic analysis showed a cutoff of 3 or higher to have a sensitivity and specificity of 70% and 79%, respectively. Patients with a score of 3 or higher had an odds ratio of 9.04 (95% confidence interval 6.06-13.46). The c-statistic obtained from 10-fold cross-validation was 0.76 (95% confidence interval 0.72-0.79), indicating good overall discrimination. CONCLUSIONS: Our data show the development and internal validation of the Barrett's Esophagus Assessment of Risk Score as capable of quantifying the likelihood of progression to dysplasia/adenocarcinoma. The Barrett's Esophagus Assessment of Risk Score can be used clinically to guide treatment decisions in nondysplastic BE patients.

Endoscopic gastrojejunostomy revision is more effective than medical management alone to address weight regain after RYGB.

BACKGROUND: Weight regain after bariatric roux-en-y gastric bypass affects up to 30% of individuals. Revisional surgery is risky, and is typically avoided in favor of dietary and psychological management. Endoscopic gastrojejunostomy revision is a low-morbidity, outpatient procedure that may be more effective than medical management alone for regain after gastric bypass. METHODS: Two patient cohorts were retrospectively assembled. Both groups had gastric bypass, regained weight, and were cleared for revision by their surgeon, dietician, and psychologist. The revision group underwent the procedure, and the no-revision group did not, typically due to insurance issues. Weights from pre-bypass to 2 years post-revision, obesity-related comorbidities, and intraoperative factors were collected and analyzed. RESULTS: There were 41 patients included in the revision group and 14 in the no-revision group. Up to the time of revision procedure, body mass index, and % excess weight loss between groups were similar. After revision, the groups diverged over a 2-year period, with improvement seen in the revision group and worsening in the no-revision group. The revision group showed overall improvement in comorbidities compared to the no-revision group. Analysis of intraoperative factors suggests that gastric pouch restriction in addition to stoma diameter reduction may promote weight loss. CONCLUSIONS: In this retrospective study, endoscopic revision provided significantly greater weight loss compared to medical management alone. Results show that revision can help resolve obesity-related comorbidities. Analysis of intraoperative factors suggests that pouch reduction at time of stoma revision may improve weight loss.

Characterization of common bile duct injury after laparoscopic cholecystectomy in a high-volume hospital system.

BACKGROUND: Despite the popularity of laparoscopic cholecystectomy, rates of common bile duct injury remain higher than previously observed in open cholecystectomy. This retrospective chart review sought to determine the prevalence of, and risk factors for, biliary injury during laparoscopic cholecystectomy within a high-volume healthcare system. METHODS: 800 of approximately 3000 cases between 2009 and 2015 were randomly selected and retrospectively reviewed. A single reviewer examined all operative notes, thereby including all cases of BDI regardless of ICD code or need for a second procedure. Biliary injuries were classified per Strasberg et al. (J Am Coll Surg 180:101-125, 1995). Logistic regression models were utilized to identify univariable and multivariable predictors of biliary injuries. RESULTS: 31.0% of charts stated that the Critical View of Safety was obtained, and 12.4% of charts correctly described the critical view in detail. Three patients (0.4%) had a cystic duct leak, and 4 (0.5%) had a common bile duct injury. Of the four CBDI, three patients had a partial transection of the CBD and one had a partial stricture. Patients who suffered BDI were more likely to have had lower hemoglobin, urgent surgery, choledocholithiasis, or acutely inflamed gallbladder. Multivariable analysis of BDI risk factors showed higher preoperative hemoglobin to be independently protective against CBDI. Acutely inflamed gallbladder and choledocholithiasis were independently predictive of CBDI. CONCLUSIONS: The rate of CBDI in this study was 0.5%. Acutely inflamed conditions were risk factors for biliary injury. Multivariable analysis suggests a protective effect of higher preoperative hemoglobin. There was no correlation of CVS with prevention of biliary injury, although only 12.4% of charts could be verified as following the technique correctly. Better implementation of CVS, and increased caution in patients with perioperative inflammatory signs, may be important for preventing bile duct injury. Additionally, counseling patients with acute inflammation on increased risk is important.

Quality of life after laparoscopic totally extraperitoneal repair of an asymptomatic inguinal hernia.

BACKGROUND: When considering an asymptomatic inguinal hernia, surgeons must weigh the risks of watchful waiting against the risk of operative complications. Laparoscopy offers the benefit of reduced postoperative pain, which, for appropriate surgical candidates, may strengthen the case for repair. This study compares general and disease-specific quality of life following totally extraperitoneal (TEP) laparoscopic inguinal hernia repair (LIHR) of asymptomatic and symptomatic hernias. METHODS: We summarize prospective data from 387 patients who underwent TEP LIHR between 2009 and 2015 by four surgeons at a single institution. Asymptomatic individuals were identified by pain scores of zero at preoperative clinic visits. Validated quality of life (QOL) measurements were administered preoperatively and at 3 weeks, 6 months, and 1-year postop. Comparisons were made using Chi-square test, t test, or Mann-Whitney U test. Changes over time were assessed using longitudinal mixed effects models. RESULTS: A cohort of 79 asymptomatic cases were compared to 308 symptomatic individuals. The asymptomatic cohort had larger median hernia defects (2.5 vs 2 cm, p < 0.01), was older (mean 63.0 vs 58.9 years, p = 0.03), included fewer indirect hernias (57.7 vs 74.9%, p < 0.01), took pain medication for fewer days (mean 1.2 ± 1.5 vs 2.2 ± 3.0 days, p = 0.02), returned to baseline activities of daily living earlier (median 3 vs 5 days, p < 0.01), and reported decreased postoperative pain (p = 0.02). There was no significant difference in general QOL. There was one recurrence in the asymptomatic group and were two in the symptomatic cohort. CONCLUSIONS: Asymptomatic individuals undergoing TEP LIHR reported less postoperative pain, returned to baseline activities, and discontinued pain medication sooner than symptomatic patients. These results are encouraging and may inform patient-centered discussions about asymptomatic hernia repair.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Primary obesity surgery endoluminal.

INTRODUCTION: Primary obesity surgery, endoluminal (POSE) is a promising procedure for weight loss surgery because it is outpatient, is incisionless and has short recovery time. We demonstrate the POSE procedure as a potential option for the bariatric patient. MATERIALS AND METHODS: Using an endoluminal camera, we videotaped one of our surgeons performing the POSE procedure. With rows of sutures in the fundus and antrum, the stomach's volume is reduced. RESULTS: We demonstrate a successful POSE procedure in its entirety. CONCLUSIONS: The POSE procedure is a promising option for the bariatric patient. Long-term studies are needed to show its efficacy.

Outcomes following 50 consecutive endoscopic gastrojejunal revisions for weight gain following Roux-en-Y gastric bypass: a comparison of endoscopic suturing techniques for stoma reduction.

BACKGROUND: Approximately 20-30 % of morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) will experience significant weight regain in the years following surgery. Endoscopic gastrojejunal revision (EGJR) has been shown to be a safe, effective and less invasive alternative to revisional surgery, with promising weight loss outcomes. However, minimal data exist regarding how to perform the procedure most effectively and what factors may predict good outcomes. We compared weight loss outcomes between patients undergoing endoscopic stoma revision by one of two full-thickness suturing techniques. METHODS: A retrospective review of patients undergoing EGJR between 06/2012 and 09/2015 was performed. Included patients were adults 18-74 years of age who had experienced weight regain ≥2 years after initial RYGB with stoma dilation ≥15 mm in diameter. Revision was done with either an interrupted (IRT) or purse-string (PST) suture technique. A linear mixed effects model was constructed to predict postoperative weight loss. RESULTS: Fifty revisions (IRT = 36, PST = 14) were performed in 47 patients (92 % female, mean age of 50.9 ± 10.9 years and body mass index of 41.4 ± 7.1 kg/m2). Technical success (stoma diameter ≤10 mm) was achieved in all cases. Final diameter was significantly smaller in the PST group, 6.6 ± 2.2 mm versus 4.8 ± 1.8 mm (p < 0.01), resulting in a significantly greater % stoma reduction (76.8 ± 8.5 % vs. 84.2 ± 5.1 %, p < 0.01) versus the IRT group. PST resulted in greater % excess weight loss over time compared to IRT. Sixteen comorbid conditions resolved among 12 patients. No major complications occurred. CONCLUSION: Endoscopic revision of the gastric outlet results in meaningful weight loss and comorbidity resolution in select patients experiencing weight regain following RYGB. A PST revision likely results in higher and more sustainable weight loss when compared to IRT.