Evaluation of Long-term Performance of the GORE SYNECOR Intraperitoneal Biomaterial in the Treatment of Inguinal Hernias.

BACKGROUND: The objective of this study was to analyze device safety and clinical outcomes of inguinal hernia repair with the GORE SYNECOR Intraperitoneal Biomaterial device, a hybrid composite mesh. METHODS: This retrospective case review analyzed device/procedure endpoints beyond 1 year in patients treated for inguinal hernia repair with the device. Three objectives were evaluated: procedural endpoint-incidence through 30 days of surgical site infection, surgical site occurrence (SSO), ileus, readmission, reoperation, and death; device endpoint-serious device incidence of mesh erosion, infection, excision/removal, exposure, migration, shrinkage, device-related bowel obstruction and fistula, and hernia recurrence through 12 months; and patient-reported outcomes of the bulge, physical symptoms, and pain. RESULTS: A total of 157 patients (mean age: 67±13 y) with 201 inguinal hernias (mean size: 5.1±5 cm 2 ) were included. Laparoscopic approach and bridging repair were performed in 99.4% of patients. All device location was preperitoneal. No procedure-related adverse events within 30 days were reported. No surgical site infection or SSO events or device-related hernia recurrence occurred through 12 months. Procedure-related serious adverse events occurred in 6 patients; 5 recurrent inguinal hernias (at 1 and 2 y) and 1 scrotal hematoma (at 6 mo). Through 24 months, no SSO events requiring procedural intervention occurred. Through 50 months, 6 (2.98%) patients had confirmed hernia recurrence and 4 (1.99%) patients had hernia reoperation. The patient-reported outcome for pain was reported by 7.9% (10/126) of patients who completed the questionnaire. CONCLUSIONS: In this study, inguinal hernia repair with the hybrid composite mesh was successful in most patients and the rate of recurrence was low, further supporting the long-term safety and device performance.

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.

A Tailored Approach to Laparoscopic Fundoplication: Outcomes in Patients with Esophageal Dysmotility.

BACKGROUND: Esophageal dysmotility is a common finding in patients being evaluated for antireflux surgery, although its implication remains unclear. We aimed to evaluate outcomes of patients with esophageal dysmotility after fundoplication. METHODS: A retrospective review of a prospective quality-database was performed. All patients who underwent laparoscopic Nissen (NF) or Toupet (TF) fundoplication were included. Esophageal dysmotility was defined using the Chicago Classification v4.0 and conventional metrics, creating three sub-groups: ineffective esophageal motility (IEM), distal/diffuse esophageal spasm (DES), and hypercontractile esophagus (HE). Quality of life (QOL) outcomes were measured by the Reflux Severity Index (RSI), Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), and Dysphagia Scores. RESULTS: Of 487 patients included, 99 (20.3%) had esophageal dysmotility (49 IEM, 40 DES, 10 HE). While a majority in the dysmotility group (81.8%) underwent TF, most patients in the normal group (76.5%) underwent NF (p < 0.001). On multivariable analysis controlling for sex, age, BMI, hiatal hernia, and surgery type, the normal group had higher Dysphagia Scores at 3 weeks (2.2 ± 0.9 vs. 1.7 ± 0.8, p < 0.001), but not at 6-month, 1-year, 2-year, or 5-year follow-up. There were no differences between normal and dysmotility groups in terms of RSI or GERD-HRQL scores at any time point. Patients with different sub-types of esophageal dysmotility had similar QOL outcomes at all time points. CONCLUSION: Patients with esophageal dysmotility had similar outcomes compared to those with normal motility after fundoplication, suggesting the tailored approach favoring partial fundoplication for patients with dysmotility as part of an appropriate treatment algorithm.

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

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.

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.

Long-term retention after structured curriculum on attainment of critical view of safety during laparoscopic cholecystectomy for surgeons.

BACKGROUND: Obtaining a clear Critical View of Safety helps prevent bile duct injuries during laparoscopic cholecystectomy, which can be improved with a structured Safe Critical View of Safety curriculum. We aimed to determine whether the improvement in obtaining Critical View of Safety postcurriculum is retained long-term. METHODS: A safe Critical View of Safety curriculum was previously implemented for all surgeons who perform laparoscopic cholecystectomy at a regional health system. Recordings of laparoscopic cholecystectomy cases were collected 1 year after completion of the curriculum, deidentified and randomly ordered, and then graded by 2 blinded expert surgeons using a 6-point Critical View of Safety assessment tool. RESULTS: A total of 12 surgeons with average experience of 17.9 ± 6.3 years in practice participated in the study. The majority (83%) had performed >700 laparoscopic cholecystectomies, and 4 surgeons (33%) reported 2 or more bile duct injuries in their career. Controlling for gallbladder pathology, Critical View of Safety scores improved from 1.7 ± 0.4 to 4.0 ± 0.4 (P < .001) immediately after completion of the curriculum. However, there was a small decrease in Critical View of Safety score after 1 year (3.2 ± 0.3 from 4.0 ± 0.4, P = .055), while still significantly higher compared to precurriculum (3.2 ± 0.3 vs 1.7 ± 0.4, P < .001). Acute care surgeons had lower Critical View of Safety retention scores compared to general surgeons (1.8 ± 0.5 vs 3.3 ± 0.4, P = .01) and minimally invasive surgeons (1.8 ± 0.5 vs 3.8 ± 0.5, P < .01). CONCLUSION: A structured curriculum helped improve practicing surgeons' attainment of obtaining the Critical View of Safety during laparoscopic cholecystectomy. However, this improvement decreased after 1 year, suggesting some decay in knowledge retention over time. Therefore, continued educational interventions on Critical View of Safety and safe laparoscopic cholecystectomy may be needed to enhance long-term retention.

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.

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.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

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.

Comparing cost and outcomes between peroral endoscopic myotomy and laparoscopic heller myotomy.

BACKGROUND: Peroral endoscopic myotomy (POEM) has previously been shown to be equally if not more expensive than laparoscopic Heller myotomy (LHM). We compare perioperative outcomes and charges between POEM and LHM at a single institution. METHODS: Outcomes and charge data of 33 patients who underwent LHM and 126 patients who underwent POEM were analyzed. Patients who did not present electively were excluded. RESULTS: There were no demographic differences between groups. Patients who underwent POEM had a significantly shorter mean operative time and median length of stay (both p < 0.001). Patients who underwent POEM stopped narcotics earlier and had faster return to activities of daily living (both p < 0.05). When adjusted for inflation, POEM incurred less in hospital charges than LHM (35.5 ± 12.8 vs 30.7 ± 10.3 in thousands of US dollars, p = 0.006). CONCLUSIONS: Patients who underwent POEM compared to LHM had significantly better perioperative outcomes. Our results suggest POEM may be the more cost-effective option.

Comparing short-term patient outcomes after fundoplication performed over a traditional bougie versus a functional lumen imaging probe.

BACKGROUND: The functional lumen imaging probe is a balloon-based catheter that can be used as a bougie during fundoplication. Our goal was to compare the short-term, quality-of-life outcomes and esophageal-injury rate after fundoplication over a functional lumen imaging probe compared to a traditional bougie. METHODS: This is a retrospective review of a quality database at a single center. Three-week and 6-month Reflux Symptom Index, Gastroesophageal Reflux Disease-health Related Quality of Life, and dysphagia scores were compared. The need for endoscopy and dilation between the groups was also compared. RESULTS: Between 2008 and 2020, 423 fundoplications were performed over a bougie and 62 over the functional lumen imaging probe. Six months after surgery, the functional lumen imaging probe group reported significantly worse dysphagia scores (1.5 ± 1.0 vs 1.1 ± 0.3, P = .007), but rates of endoscopy (4.8% vs 5.0%, P = .966) and dilation (4.8% vs 3.8%, P = .723) were similar. There were no differences between Reflux Symptom Index and Gastroesophageal Reflux Disease-health Related Quality of Life scores. The rate of bougie-related injuries was 2.1% vs 0% for the functional lumen imaging probe group. CONCLUSION: Patients undergoing fundoplication over the functional lumen imaging probe had comparable short-term outcomes compared with those over a traditional bougie. The rate of esophageal injury while using the functional lumen imaging probe is lower than a bougie and may be preferable for fundoplication creation.

Predictors of chronic pain after laparoscopic inguinal hernia repair.

BACKGROUND: Multiple studies have analyzed predictors for chronic pain after open hernia repair. The purpose of this study is to determine which factors predict the development of chronic pain after a laparoscopic inguinal hernia repair. METHODS: We identified patients who underwent laparoscopic inguinal hernia repair between 2008 and 2020 at a single institution. Quality of life was measured using the Surgical Outcomes Measurement System and Carolinas Comfort Scale. We categorized patients with chronic pain if their score on Carolinas Comfort Scale was greater than or equal to 3. Multivariable logistic regression analysis was used to identify predictors of chronic pain. RESULTS: A total of 960 patients met inclusion criteria. Mean age was 59 (± 14, standard deviation) years, 89 (9.3%) of whom were female. Six percent of patients met criteria for chronic pain (Carolinas Comfort Scale ≥3). On multivariable analysis, predictors for chronic pain were age 45 (P < .001), female sex (P = .006), preoperative pain visual analog scale ≥1 (P = .025), prior inguinal hernia repair (P = .045), higher American Society of Anesthesiologists class (P = .041), use of multifilament polyester mesh (P = .0448), and intraoperative placement of a urinary catheter (P = .009). CONCLUSION: Laparoscopic inguinal hernia repair results in 6.0% of patients experiencing chronic pain. We identified multiple predictors for chronic pain.

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.

Teaching peroral endoscopic pyloromyotomy (POP) to practicing endoscopists: An "into-the-fire" approach to simulation.

BACKGROUND: Peroral endoscopic pyloromyotomy, or gastric peroral endoscopic myotomy, is a novel endoscopic procedure for the treatment of refractory gastroparesis. We present a simulation-based curriculum using an "into-the-fire" approach with hands-on pre- and post-tests to teach this procedure. METHODS: Six, 1-day peroral endoscopic pyloromyotomy courses were taught by an expert surgical endoscopist in 2018 to 2019. The curriculum is composed of a series of pretraining tests, lectures, mentored hands-on instruction, and post-training tests using porcine models. Both pre- and post-testing included a confidence survey, a knowledge-based written test, and a specific assessment form for the peroral endoscopic pyloromyotomy procedure. Participants' scores were analyzed using paired t tests. RESULTS: Twenty-eight practicing physicians participated. After completing the curriculum, participants had improved confidence scores (10.5 ± 5.2 vs 19.4 ± 3.6; P < .001), written test scores (6.8 ± 1.6 vs 8.0 ± 1.1; P < .001), and hands-on performance scores (23.6 ± 3.4 vs 29.3 ± 1.4; P < .001) with marked improvement in all components of the peroral endoscopic pyloromyotomy procedure. Postcourse surveys showed 93% of participants had performed or intended to perform the peroral endoscopic pyloromyotomy procedure within the next year. CONCLUSION: Our simulation curriculum with an into-the-fire approach to teach peroral endoscopic pyloromyotomy is effective in improving practitioner knowledge, confidence, and technical skills, leading to an increase in the adoption of this procedure.