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 13-year experience with biologic and biosynthetic absorbable mesh reinforced laparoscopic paraesophageal hernia repair.

BACKGROUND: Mesh reinforced cruroplasty during laparoscopic paraesophageal hernia repair remains controversial due to wide variation in surgical technique and mesh composition. This study aims to review outcomes and rates of recurrence following laparoscopic paraesophageal hernia repair (LPEHR) with mesh reinforced cruroplasty utilizing absorbable mesh at a single institution. METHODS: A retrospective review of all patients who underwent LPEHR with mesh was performed. Medical records were reviewed for patient reported, radiographic or endoscopic evidence of recurrence, defined as > 2 cm of vertical intrathoracic stomach. If no studies were available for review, patients were considered to have no recurrence. Outcomes and mesh-related complications were also reviewed. RESULTS: Between 10/2008 and 9/2021, 473 patients underwent LPEHR with absorbable mesh; 1.3% type 2 hernias, 86.0% type 3 hernias, 12.7% type 4 hernias. Three types of mesh were used: initially biologic mesh (n = 83), then heavyweight synthetic bioabsorbable mesh (n = 261), and finally lightweight synthetic bioabsorbable mesh (n = 111). There were no significant differences in age, ASA, BMI, gender, smoking status, chronic steroid use, preoperative acid suppression, hernia type, or recurrent hernia between groups. There were no significant differences in 30-day postoperative outcomes. Reflux Symptom Index, GERD-HRQL, and Dysphagia Scores at 1- and 2-year postoperative timepoints were not significantly different. The overall recurrence rate was 16.7%, with no significant differences in recurrence rates between biologic, heavyweight or lightweight biosynthetic absorbable mesh through 2 years after surgery. A shorter median time to recurrence (10 months, p = 0.016) was seen in the lightweight group. CONCLUSION: LPEHR with absorbable mesh reinforced cruroplasty is feasible and safe, with equivalent patient-reported outcomes, including dysphagia, up to 2-years postop regardless of mesh choice. No significant differences in recurrence rates between biologic, heavyweight, or lightweight synthetic bioabsorbable mesh were seen up to 2 years after LPEHR.

"Into the fire" approach to teaching endoscopic foreign body removal using a modular simulation curriculum.

BACKGROUND: As flexible endoscopy becomes an increasingly valuable minimally invasive approach to surgical challenges, an efficient and comprehensive training curriculum is needed to train surgeons in therapeutic endoscopy. We developed a modular curriculum utilizing a simulation-based, "into the fire" approach to endoscopic foreign body removal for practicing physicians with task performance pre- and post-testing. METHODS: From 2020 to 2021, two sessions of our advanced flexible endoscopy course were taught by two expert surgical endoscopists using ex-vivo porcine models. The course focused on safe removal techniques for various foreign bodies as part of an overall endoscopy curriculum that uses hands-on simulation-based pre-testing, didactics, and mentored practice sessions, followed by post-course examination. Pre- and post-course assessments and surveys were used to evaluate knowledge, performance, and confidence of participants, and subsequently analyzed using the Wilcoxon-signed rank test. RESULTS: Of the 16 practicing physicians who participated in the course, 43.8% were certified in Fundamentals of Endoscopic Surgery, and 62.5% had completed > 200 prior upper endoscopies. Upon course completion, scoring on knowledge-based written examinations improved from 3.4 ± 1.9 to 5.8 ± 2.0 (p < 0.001). Technical facility of each participant demonstrated significant overall improvement with post-course score increased from 15.8 ± 2.5 to 23.6 ± 1.6 (p < 0.001), with skill refinement noted in technical subcategories of appropriate instrument use (p < 0.001), foreign body manipulation (p < 0.001), and successful foreign body removal (p < 0.001). Confidence surveys likewise demonstrated significant increase in confidence after completion of the curriculum 11.6 ± 3.4 to 23.0 ± 5.5 (p < 0.001). CONCLUSIONS: The "into the fire" approach to teaching endoscopic foreign body removal utilizing our simulation module provides an effective curriculum to improve knowledge, confidence, and overall technical performance. Our methodology utilizes hands-on, simulation-based pre-testing prior to instruction. This introduces clinical scenarios and technical challenges, while accounting for and tailoring to provider-specific variation in knowledge and experience, facilitating training efficiency.

Resident performance in simulation module is associated with operating room performance for laparoscopic cholecystectomy.

BACKGROUND: Simulation is an important tool in surgical training. However, the transferability of skills obtained in the simulation setting to the operating room (OR) is uncertain. This study explores the association between resident simulation performance and OR performance in a laparoscopic cholecystectomy (LC) simulation module. METHODS: A simulation module focused on LC utilizing a virtual reality simulator was completed by general surgery residents. Simulation performance was evaluated using the validated Global Operative Assessment of Laparoscopic Skills (GOALS) and Objective Structured Assessment of Technical Skills (OSATS), as well as a LC-specific simulation assessment form (LC-SIM). Resident subsequent OR performances of LC were measured by the Surgical Training and Assessment Tool (STAT), an online mobile-based evaluation completed by attending surgeons. RESULTS: Twenty-one residents who completed the simulation module and also with STAT data on LC from 2016 to 2020 were included. Higher scores on incision/port placement on LC-SIM is associated with better tissue handling (coefficient 0.20, p = 0.048) and better time & economy of motion on STAT (coefficient 0.22, p = 0.037). However, higher scores on time and motion on OSATS are associated with worse tissue handling (- 0.28, p = 0.046), worse time & economy of motion (- 0.37, p = 0.009), and worse overall grade (- 0.21, p = 0.044). Higher scores on overall performance on OSATS is associated with worse time & economy of motion (- 0.80, p = 0.008). Higher scores on depth perception on GOALS are associated with worse tissue handling (- 0.28, p = 0.044). CONCLUSION: We found significant positive and negative associations between resident simulation performance and OR performance, particularly in tissue handling and economy of motion. This could suggest that simulation performance does not reliably predict OR performance. However, this could highlight the concept of excessive caution in the real OR environment and longer operative time which could be interpreted as worse time and economy of motion by the attending surgeons.

Changes in impedance planimetry (EndoFLIP) measurements at follow-up after peroral endoscopic myotomy (POEM).

BACKGROUND: Numerous studies show changes in functional lumen imaging probe (FLIP) measurements after myotomy during peroral endoscopic myotomy (POEM), but few report on FLIP measurements at follow-up esophagogastroduodenoscopy (EGD). The purpose of this study was to compare perioperative FLIP measurements to those at follow-up EGD. METHODS: Patients who underwent POEM with FLIP in the operating room and POEM patients who had EGD with FLIP at follow-up were included. FLIP measurements, including diameter (Dmin), pressure, cross-sectional area (CSA), and distensibility index (DI), were analyzed at a 30-mL balloon fill. Differences between measurements at different timepoints were assessed using a two-tailed Wilcoxon signed-rank test. RESULTS: A total of 97 patients who underwent POEM and 28 who underwent EGD with FLIP were analyzed. The average age was 63 ± 18 years and 46.4% of the patients were male. Mean preoperative Eckardt score was 6.5 ± 4.8, decreasing to 1.6 ± 2.0 at follow-up. EGDs were performed at a median of 15 months after surgery. When compared to mean measurements obtained post-myotomy, at the time of EGD, pressure was found to be significantly lower (p = 0.007) and DI significantly higher (p = 0.045). Of the patients who underwent EGD, 70.8% had an increase in DI, 55.6% had evidence of reflux esophagitis, and 81.0% met diagnostic criteria for reflux on esophageal pH monitoring. However, there was no correlation with the development of esophagitis or reflux and increase or decrease in DI at follow-up. CONCLUSIONS: There are significant changes in FLIP measurements between the time of surgery and at follow-up EGD. These results suggest that esophageal remodeling may cause changes in lower esophageal sphincter geometry after POEM and postoperative FLIP targets immediately post-myotomy may need to be adjusted to account for these changes.

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.

Impedance planimetry (EndoFLIP™) reveals changes in gastroesophageal junction compliance during fundoplication.

INTRODUCTION: Compliance is the ability of a hollow organ to dilate and increase volume with an increase in pressure, an accurate representation of food bolus transit through the gastroesophageal junction (GEJ). Impedance planimetry system can calculate compliance (change in volume over pressure) and distensibility (cross-sectional area over pressure) of the GEJ. We aim to describe the changes in compliance during anti-reflux surgery and hypothesize that compliance is a better predictor of patient outcomes than distensibility (DI). METHODS AND PROCEDURES: A review of a prospectively maintained quality database was performed. Patients with FLIP measurements during laparoscopic fundoplication between August 2018 and June 2021 were included. GEJ compliance and DI were measured after hernia reduction, cruroplasty, and fundoplication. Patient-reported outcomes were collected through standardized surveys up to 2 years after surgery. A scatter plot was used to identify a correlation between compliance and DI. Comparisons of measurements between time points were made using paired t-tests. Spearman's correlation coefficients (ρ), Wilcoxon rank-sum, and chi-square tests were used to evaluate associations between measurements and outcomes. RESULTS: One hundred and forty-four patients underwent laparoscopic fundoplication. Compliance is strongly associated with DI (r = 0.96), and a comparison of measurements showed similar trends at specific time points during the operation. After hernia reduction, compliance at the GEJ was 168 ± 74 mm3/mmHg, cruroplasty 79 ± 39 mm3/mmHg, and fundoplication 90 ± 33 mm3/mmHg (all comparisons p < 0.05). GEJ compliance of 80-92 mm3/mmHg after fundoplication was associated with the best patient-reported outcome scores. A compliance of ≤ 79 mm3/mmHg had the highest percentage of patients who reported dysphagia. CONCLUSIONS: Compliance and DI are strongly associated displaying the same directional change during anti-reflux surgery. GEJ compliance of 80-92 mm3/mmHg revealed the best patient-reported outcome scores, and avoiding a compliance ≤ 79 mm3/mmHg may prevent postoperative dysphagia. Therefore, GEJ compliance is an underutilized FLIP measurement warranting further investigation.

Impedance planimetry (EndoFLIP™) after magnetic sphincter augmentation (LINX®) compared to fundoplication.

INTRODUCTION: Functional luminal imaging probe (FLIP) use during laparoscopic fundoplication (LF) for gastroesophageal reflux disease is well described. However, there is a lack of data on FLIP measurements during magnetic sphincter augmentation (MSA). This study aims to report our institutional experience in performing FLIP during MSA and to compare these measurements to those obtained during Nissen and Toupet fundoplication. METHODS AND PROCEDURES: A retrospective review of a prospectively maintained quality database was performed. Patients who underwent MSA or LF and had FLIP measurements between April 2018 and June 2021 were included. FLIP measurements at the gastroesophageal junction (GEJ) were recorded without pneumoperitoneum at 40 mL balloon fill after hernia reduction, cruroplasty, and MSA or fundoplication. Reflux symptom index (RSI), GERD-HRQL, and dysphagia score were collected up to 2 years. Group comparisons were made using two-tailed Wilcoxon rank-sum and χ2 tests, with statistical significance of p < 0.05. RESULTS: Twenty-seven patients underwent MSA and 100 patients underwent LF (66% Toupet, 34% Nissen). Type III hiatal hernia was present in 3.7% of MSA patients versus over 50% for fundoplication patients. Minimum diameter, cross-sectional area, and distensibility index (DI) were lower after MSA device placement compared to Nissen or Toupet fundoplication (p < 0.05). Postoperative follow-up showed no differences in RSI, GERD-HRQL, and dysphagia score between MSA and Nissen fundoplication (p > 0.05). CONCLUSION: Intraoperative impedance planimetry provided objective information regarding the geometry of the GEJ during MSA. The ring of magnetic beads restores the anti-reflux barrier and transiently opens with food bolus and belching. The magnetic force of the beads may explain why the DI after MSA is lower yet postoperative quality of life is no different than Nissen fundoplication.

Significant changes in impedance planimetry (EndoFLIP™) measurements after peroral pyloromyotomy for delayed gastric emptying.

BACKGROUND: The endoluminal functional lumen imaging probe (FLIP) can be used to obtain real-time measurements of the diameter (Dmin), cross-sectional area (CSA), and distensibility of the pylorus before and after peroral pyloromyotomy (POP), an emerging endoscopic treatment for delayed gastric emptying. Our study aims to report our single-center experience in performing POP with FLIP measurements before and after pyloromyotomy. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed. Demographic and perioperative data, including intraoperative FLIP measurements of the pylorus before and after POP, were analyzed. Measurements were compared using paired t tests. RESULTS: Thirty-four patients underwent POP between February 2017 and July 2020. Twenty-three (67.7%) patients were male and the average age was 59 years. The etiology of delayed gastric emptying was post-vagotomy in 22 patients, idiopathic gastroparesis in 7 patients, and diabetic gastroparesis in 5 patients. There were no significant differences in pre-myotomy or post-myotomy FLIP measurements when comparing the post-vagotomy versus the gastroparesis groups. There were significant increases in Dmin, CSA, and distensibility index when comparing pre-myotomy and post-myotomy readings for all patients (all p < 0.001). At follow-up, 64.7% of patients reported resolution of all symptoms. CONCLUSION: POP is an effective intervention in patients with delayed gastric emptying. Significant changes in FLIP measurements before and after POP suggest that FLIP may be a useful adjunct in guiding the management of delayed gastric emptying.

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.

Laparoscopic totally extraperitoneal and transabdominal preperitoneal approaches are equally effective for spigelian hernia repair.

INTRODUCTION: Spigelian hernias (SH) are rare intraparietal abdominal wall hernias occurring just medial to the semilunar line. Several small series have reported on laparoscopic SH repair and both totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) approaches have been described. However, there are limited outcome data including both of these techniques. We present the largest series to date of laparoscopic SH repair comparing both popular approaches. METHODS: Consecutive patients (n = 77) undergoing laparoscopic SH repair from 2009 to 2019 were identified from a prospectively managed quality database. All procedures were performed at a single institution. Patients were divided based on laparoscopic approach used, TEP group (n = 37) and TAPP group (n = 40). Comparison of patient demographics, surgical characteristics, and post-operative complications between TAPP and TEP groups was made using the Wilcoxon rank-sum and Fisher's exact tests. RESULTS: Individuals undergoing TAPP had higher mean BMI (29.3 ± 5.4 vs. 26.3 ± 5.6 kg/m2; p = 0.019) and were more likely to have had prior abdominal surgery (65% vs 24.3%, (p < 0.001). Mean procedure length was 77 ± 45 min for TAPP repairs and 48 ± 21 for TEP repairs (p = 0.001). TAPP repairs had a significantly longer median LOS than TEP (25 vs. 7 h; p < 0.001). Days of narcotic use were significantly shorter after TEP repair than for TAPP (0 vs. 3; p = 0.007) and return to ADL was significantly shorter after TEP repair than for TAPP (5 vs. 7 days; p = 0.016. There were no significant differences in readmission, reoperations, SSI, or recurrence between the two groups. CONCLUSION: Our large series revealed that both preperitoneal laparoscopic approaches, TEP, and TAPP, for SH repair are equally safe, effective, and can be performed on an outpatient basis. Therefore, we suggest that the approach used for repair should be based on surgeon experience, preference, and individual patient factors.

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.

Factors associated with admission after implementation of a same-day discharge pathway in patients undergoing peroral endoscopic myotomy (POEM).

BACKGROUND: Although peroral endoscopic myotomy (POEM) has emerged as a highly efficacious procedure in the treatment of a variety of esophageal motility disorders, currently no standard pathway for postprocedural care exists. Our study aims to report institutional outcomes in performing POEM as an outpatient procedure with same-day discharge. Additionally, we seek to determine factors associated with admission. METHODS: Demographic, perioperative, and postoperative outcome data of 115 patients who underwent POEM between June 2014 and January 2020 on a same-day discharge pathway were analyzed. Cohorts were compared using the t test, Wilcoxon rank-sum, or chi-square test. Multivariable logistic regression with a manual backward selection method was used to identify factors associated with admission. RESULTS: Fifty-five patients (48%) were successfully discharged same-day. The most common primary reasons for admission were delay in obtaining an esophagram (25%), intraoperative complication (13.3%), and pain (10%). There were no differences in 30-day ED visit rate (12.7% vs 15.0%, p = 0.725) or 30-day readmission rate (9.1% vs 16.7%, p = 0.373) between patients who were discharged same-day versus patients who were admitted. Patients discharged same-day had fewer intraoperative complications (1 vs 9, p = 0.017), shorter OR time (69 vs 100 min, p < 0.001), and earlier cessation of narcotic use (day 0 vs day 1, p = 0.001). On multivariable analysis, intraoperative complication (p = 0.048) was associated with overnight admission. CONCLUSION: Patients did not experience additional morbidity with same-day discharge after POEM. A delay in obtaining an esophagram was the most common reason that patients were admitted and those who suffered an intraoperative complication are more likely to require admission.

Short-term quality of life comparison of laparoscopic, open, and robotic incisional hernia repairs.

BACKGROUND: Outcomes of incisional hernia repair (IHR) include recurrence and quality of life (QOL). Operative approaches include laparoscopic, open, and robotic approaches. Data regarding comparative QOL outcomes among these repair types are unknown. Our study evaluates quality of life after three approaches to IHR. STUDY DESIGN: Patients undergoing open (OHR), laparoscopic (LIHR), and robotic extra-peritoneal (RIHR) at a single institution from 2009 to 2019 were reviewed from a prospectively managed quality database. Short-term QOL was compared among the three procedures using the Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CCS), objective pain scores and postoperative narcotic use. Data regarding length of stay (LOS), emergency department (ED) visits, readmission, reoperations and surgical site infection (SSI) were also collected. RESULTS: A total of 795 patients undergoing IHR were analyzed (418 open, 300 laparoscopic and 77 robotic). Patient were similar in age, gender and co-morbidities. LIHR patients had higher BMI and RIHR patients had larger hernia and mesh size. LOS was longer and rate of SSI was higher for OIHR compared to laparoscopic and RIHR. Patients undergoing LIHR reported increased narcotic use, Visual Analogue Scale (VAS) and CCS pain scores compared to open and robotic repair. Return to daily activity was 4 days shorter for robotic than open and laparoscopic repair; ED visits, readmissions, reoperations, and other QOL domains were similar. CONCLUSION: Our data suggests that short-term quality of life after robotic extra-peritoneal IHR is improved compared to open and laparoscopic repair. Additional follow up is required to determine differences in long-term QOL after IHR.

Intraoperative impedance planimetry (EndoFLIP™) results and development of esophagitis in patients undergoing peroral endoscopic myotomy (POEM).

INTRODUCTION: Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for achalasia. Considerable evidence demonstrates a high incidence of gastroesophageal reflux disease (GERD) after POEM. The endoluminal functional lumen imaging probe (FLIP) uses impedance planimetry to obtain objective measurements of the gastroesophageal junction. This study aims to determine whether FLIP measurements collected at the time of POEM are associated with the development of reflux esophagitis postoperatively. METHODS: Patients who underwent POEM between 2012 and 2019 who subsequently had esophagogastroduodenoscopy (EGD) were included. Intraoperative FLIP measurements before and after myotomy, clinical data from EGD, and reflux specific quality of life questionnaires were collected. Comparisons between groups were made using the Wilcoxon rank-sum and Fisher's exact tests. Receiver operating characteristic (ROC) curves were used to determine optimal cutoffs of measurements to classify patients into those with high risk of postoperative esophagitis and those with lower risk. RESULTS: A total of 43 patients were included. Of those, 25 (58.1%) were found to have esophagitis on postoperative EGD: four patients (16%) with LA Grade A, five (20%) with LA Grade B, 11 (44%) with LA Grade C and two (8%) with LA grade D esophagitis. Patients with a final distensibility index ≥ 2.7 and a final cross-sectional area ≥ 83 were significantly more likely to develop esophagitis on postoperative EGD (p = 0.016 and p = 0.008, respectively). Gastroesophageal reflux disease health-related quality of life (GERD-HRQL) and reflux symptom index (RSI) scores were not significantly different in patients who developed esophagitis and those who did not. CONCLUSION: Reflux affects some patients after POEM. We show that FLIP measurements collected during POEM may help predict which patients are more likely to develop reflux esophagitis postoperatively. Subjective symptoms on quality of life questionnaires are not reliable in determining which patients are at risk for esophagitis.

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.