The effect of per-oral endoscopic myotomy by achalasia subtype as measured by impedance planimetry.

BACKGROUND: Achalasia is an esophageal motility disorder with three subtypes based on manometry that can treated with per-oral endoscopic myotomy (POEM). With the advent of impedance planimetry (EndoFLIP®), we hypothesized the three achalasia subtypes would have different pre-POEM EndoFLIP® diameter and distensibility index (DI) measurements but would be similar after POEM. METHODS: A single-institution, retrospective review of consecutive POEM cases by a single surgeon-endoscopist team from 04/07/2017 to 08/28/2023. Patients with a diagnosis of achalasia were stratified into type 1, 2, or 3 based on pre-POEM manometry. Patient characteristics, Eckardt scores, and pre-and-post-POEM diameter and DI were compared by subtype with descriptive, univariate, and multivariable linear regression statistics. RESULTS: Sixty-four patients met inclusion criteria, of whom 9(14.1%) had Type 1, 36(56.3%) had Type 2, and 19(29.7%) had Type 3. There were no differences between Types with respect to median pre-POEM Eckardt scores (9[IQR:7-9) vs. 8[IQR:6-9] vs. 7[IQR:5-8], p = 0.148), median post-POEM Eckardt scores (0[IQR:0-1] vs. 0[IQR:0-0] vs. 0[IQR0-0.5], p = 0.112). EndoFLIP® data revealed variation in median pre-POEM diameter and DI between Subtypes (6.9[IQR:6-8.5] vs. 5.5[IQR:5-6.8] vs. 5[IQR:5-6.1], p = 0.025 and 1.8[IQR:1.3-3.2] vs. 0.9[IQR:0.6-1.6] vs. 0.6[IQR:0.5-0.8], p = 0.003, respectively), but not in the change in diameter or DI post-POEM (5.1[IQR:4.3-5.9] vs. 5.1[IQR:4.1-7.1] vs. 5.9[IQR:5-6.4], p = 0.217 and 3.9[IQR:2.5-4.7] vs. 3.4[IQR:2.4-4.7] vs. 2.7[IQR:2.3-3.7], p = 0.461, respectively). However, after adjusting for potentially confounding factors, pre- or post-POEM diameter and DI did not demonstrate statistically significant differences among subtypes. CONCLUSIONS: Achalasia subtypes did not demonstrate different pre-POEM diameters or DI as measured by EndoFLIP® nor are there differences after POEM completion. While achalasia subtypes may have slightly different pathophysiology based on manometry findings, similar pre- and post-POEM impedance planimetry findings, along with similar Eckardt scores, support the use of POEM in the treatment of any achalasia subtype.

Impedance planimetry during per-oral endoscopic myotomy is associated with decreased inadvertent capnoperitoneum.

BACKGROUND: Per-oral endoscopic myotomy (POEM) has become an accepted minimally invasive alternative to Heller myotomy for the treatment of achalasia and other disorders of esophageal dysmotility. One associated adverse event is the inadvertent creation of capnoperitoneum. A proposed mechanism is that extension of the submucosal tunnel below the esophageal hiatus and onto the gastric wall leads to transmural perforation. We hypothesized that the use of impedance planimetry with the endoscopic functional luminal imaging probe (EndoFLIP) more accurately identifies the esophagogastric junction and helps to better define the myotomy's ideal limits, thus lowering the incidence of inadvertent capnoperitoneum. METHODS: This is a single-center, retrospective review of consecutive POEM cases from 06/11/2011 to 08/08/2022, with EndoFLIP introduced in 2017. Patient and procedural characteristics, including the incidence of clinically significant capnoperitoneum and decompression, were analyzed using univariate and multivariable linear regression statistics. RESULTS: There were 140 POEM cases identified, 74 (52.9%) of which used EndoFLIP. Clinically significant capnoperitoneum was encountered in 26 (18.6%) cases, with no differences in patient characteristics between those who had capnoperitoneum and those who did not. There was a decreased incidence of capnoperitoneum in cases using EndoFLIP compared to those without (n = 6, 23% vs n = 20, 77%, p = 0.001), with zero instances in the final 56 cases. After adjusting for potentially confounding factors, EndoFLIP use was associated with a - 15.93% (95% confidence interval - 30.68%, - 1.18%) decrease in procedure duration. CONCLUSIONS: The routine use of EndoFLIP during POEM was associated with decreased incidence of clinically significant capnoperitoneum, potentially due to improved myotomy tailoring and decreased duration of insufflation with shorter procedure times.

What role does the submucosa play in the pathophysiology and treatment of achalasia? An analysis of impedance planimetry during POEM.

BACKGROUND: It is thought the therapeutic benefit of per-oral endoscopic myotomy (POEM) in the treatment of esophageal dysmotility disorders is from longitudinal myotomy creation, but it is unknown if the submucosa contributes to the pathophysiology. This study investigates if submucosal tunnel (SMT) dissection alone contributes to POEM's luminal changes as measured by EndoFLIP. METHODS: A single-center, retrospective review of consecutive POEM cases from June 1, 2011 to September 1, 2022 with intraoperative luminal diameter and distensibility index (DI) data as measured by EndoFLIP. Patients with diagnoses of achalasia or esophagogastric junction outflow obstruction were grouped by those with pre-SMT and post-myotomy measurements (Group 1) and those with a third measurement post-SMT dissection (Group 2). Outcomes and EndoFLIP data were analyzed using descriptive and univariate statistics. RESULTS: There were 66 patients identified, of whom 57 (86.4%) had achalasia, 32 (48.5%) were female, and median pre-POEM Eckardt score was 7 [IQR: 6-9]. There were 42 (64%) patients in Group 1, and 24 (36%) patients in Group 2, with no differences in baseline characteristics. In Group 2, SMT dissection changed luminal diameter by 2.15 [IQR: 1.75-3.28]cm, which comprised 38% of the median 5.6 [IQR: 4.25-6.3]cm diameter of complete POEM change. Similarly, the median post-SMT change in DI of 1 [IQR: 0.5-1.2]units comprised 30% of the median 3.35 [2.4-3.98]units overall change in DI. Post-SMT diameters and DI were both significantly lower than the full POEM. CONCLUSIONS: Esophageal diameter and DI are significantly affected by SMT dissection alone, though not equaling the magnitude of diameter or DI changes from full POEM. This suggests that the submucosa does play a role in achalasia, presenting a future target for refining POEM and developing alternative treatment strategies.

Per-oral endoscopic myotomy for the treatment of non-achalasia esophageal dysmotility disorders: experience from a single high-volume center.

BACKGROUND: Achalasia is a rare disorder of esophageal motility that induces progressive intolerance to oral intake. Other esophageal dysmotility disorders include esophagogastric junction outflow obstruction (EGJOO), distal esophageal spasm (DES), hypercontractile esophagus (HE), and other minor disorders of peristalsis (MDP) and can present similarly to achalasia despite different pathophysiologies. Prior studies have demonstrated the safety and efficacy of POEM in the treatment of achalasia, but little is reported regarding POEM's role in treating non-achalasia esophageal dysmotility disorders (NAEDD). This study aims to assess the safety and efficacy of POEM in the treatment of NAEDD. STUDY DESIGN: This is a retrospective review of consecutive POEM cases from June 1, 2011, to February 1, 2021. NAEDD were characterized according to the Chicago classification. Primary outcome measure was the resolution of preoperative symptoms. Secondary outcomes include preoperative diagnosis, myotomy length, conversion to laparoscopic or open procedure, operative time, and length of stay (LOS). Technical success was defined as the completion of an 8 cm myotomy including the esophagogastric junction (EGJ) and extending 2 cm distal to the EGJ. Clinical success was defined as a postoperative Eckardt score ≤ 3. RESULTS: Of 124 cases of POEM performed during the study period, 17 were performed for NAEDD. Technical success was achieved in all 17 patients (100%). Of the fifteen patients that had documented postoperative Eckardt scores, 13 were ≤ 3, achieving a clinical success rate of 87%. Subgroup analysis (HE/MDP/DES vs. EGJOO) showed no significant differences in the preoperative or postoperative Eckardt scores between groups, and both groups demonstrated a significant decrease in Eckardt scores after POEM. No cases were aborted for technical or clinical reasons, and there were no adverse outcomes. CONCLUSION: POEM is a safe and efficacious treatment modality for NAEDD. Further work is needed to develop optimal treatment strategies for this complex group of diseases.

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.

Metabolic and bariatric surgery is likely safe, but underutilized in adolescents aged 13-17 years.

BACKGROUND: Bariatric surgery is now accepted for adolescents; however, we may need to improve access to surgery for this vulnerable age group. OBJECTIVES: To compare the demographic characteristics and short-term safety outcomes of adolescents, college-aged individuals, and young adults who have had metabolic and bariatric surgery. SETTING: Bariatric surgery centers. METHODS: Patients aged 13-25 years in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from 2015-2018 with a Current Procedural Terminology (CPT) code for sleeve gastrectomy (SG) or gastric bypass (GB) were included. Patients were stratified by operation and analyzed by age: adolescents (13-17 yr), college-aged (18-21 yr), and young adults (22-25 yr). RESULTS: Of the 760,076 patients in the database, 1047 adolescents (.1%), 10,429 college-aged individuals (1.4%), and 24,841 young adults (3.8%) underwent SG or GB. The majority of patients in each group were female and white. Diabetes was most common among adolescents, hypertension among college-aged individuals. The most prevalent co-morbidity among young adults was diabetes. Preoperative BMI was 47 across all age strata. SG was performed in 27,292 patients: 879 (3.2%) adolescents, 7955 (29.2%) college-aged, and 18,447 (67.6%) young adults. Postoperative complications occurred in approximately 1% of individuals and were similar between age groups (P = .23). A total of 8292 patients underwent GB: 146 (1.8%) adolescents, 2207 (26.6%) college-aged, and 5939 (71.6%) young adults. There was no difference in 30-day complication rates between age groups (P = .32). CONCLUSIONS: There may be a disparity in access to metabolic and bariatric surgery among adolescents, particularly for racial and ethnic minorities; however, these procedures are likely safe in adolescents as young as 13.

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.

S054: incidence and management of jejunojejunal intussusception after Roux-en-Y gastric bypass: a large case series.

INTRODUCTION: Jejunojejunal intussusception after Roux-en-Y gastric bypass (RYGBP) for morbid obesity is a rare but potentially catastrophic complication. There are limited data regarding the incidence of intussusception and the different surgical options for management of this disease. METHODS: This is a retrospective review of all patients that underwent RYGBP and subsequently developed intussusception at the jejunojejunostomy. Data were collected between 1/1/2008 and 5/31/2018 and included demographics, details related to the index procedure, presentation, and management of intussusception. Perioperative outcomes and complications were also collected. RESULTS: 665 patients underwent RYGBP. A total of 34 patients developed intussusception, with 31 (4.7%) of them having undergone RYGBP in our hospital. Demographics included age, gender, and BMI at both the index surgery and at the time of intussusception. The jejunojejunostomy was created during RYGBP using a linear stapler in all patients with 64.5% of them achieving a length of 90 mm. All intussuscepted patients presented acutely with abdominal pain. All but one patient required surgical intervention. 42.4% of the patients were found to have intraoperative intussusception which appeared to be retrograde in 78.6% of them. Reduction followed by enteropexy or just enteropexy was performed in 20 patients (60.6%) that required surgery. No immediate post-operative complications were noted but 8 patients (26.5%) had recurrence of intussusception requiring another surgical intervention. In the reoperated group, 75% of the patients were treated with reduction followed by enteropexy or just enteropexy. CONCLUSIONS: This is the largest case series describing jejunojejunal intussusception following RYGBP. All patients that developed intussusception had jejunojejunostomy length greater than 60 mm. The most commonly performed surgical repair was reduction of the intussuscepted segment (if present) followed by enteropexy. Jejunojejunostomy length greater than 60 mm might be associated with the occurrence of intussusception and could explain the higher incidence noted in our series. Minimal intervention with enteropexy can offer effective treatment for most patients.

Public reporting and transparency: a primer on public outcomes reporting.

INTRODUCTION: Healthcare consumers seeking accurate information about where to find quality surgical care face a confusing constellation of rating systems that lack transparency or consistency of opinion. For example, a 2016 report in Health Affairs demonstrated that no hospital was rated as a high performer by all four prominent national ratings systems: Consumer Reports, Leapfrog, Healthgrades and U.S. News & World Report (Austin et al. Health Aff 34:423-430, 2015). Surgeons should have an understanding of the current state of public reporting of quality; hospital ratings and data sources; physician ratings and data sources; and transparency of reporting. METHODS: We conducted a non-systematic review of the literature. RESULTS: Hospital quality ratings remain nebulous and there is not universal opinion on the utility of voluntary participation in ranking systems, leaving the current systems largely opinion-based. Early attempts at physician ranking systems are rudimentary at best and suffer from methodological concerns. Publicly reported metrics should be easily understandable, accessible, clinically relevant, reliable, non-punitive, and shielded from legal discovery. Transparency is increasing within institutions to help align staff to institutional objectives, while specialty specific registries are helping to standardize care pathways and outcomes measures across organizations. Measuring surgical outcomes beyond 30-day morbidity and mortality has been plagued by a lack of understanding on how to create metrics that matter; the four attributes of relevance, scientific soundness, feasibility and comprehensiveness set a high bar for the development of effective and efficient quality measures in surgery. DISCUSSION: SAGES, via the Quality, Outcomes, and Safety Committee, is committed to learning how to develop meaningful quality metrics in general surgery and will continue to work in other areas that impact quality, such as opioid prescribing, and surgeon wellness.

Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia.

INTRODUCTION: High-resolution esophageal manometry (HREM) is essential in characterizing achalasia subtype and the extent of affected segment to plan the myotomy starting point during per-oral endoscopic myotomy (POEM). However, evidence is lacking that efficacy is improved by tailoring myotomy to the length of the spastic segment on HREM. We sought to investigate whether utilizing HREM to dictate myotomy length in POEM impacts postoperative outcomes. METHODS: Comparative analysis of HREM-tailored to non-tailored patients from a prospectively collected database of all POEMs at our institution January 2011 through July 2017. A tailored myotomy is defined as extending at least the length of the diseased segment, as initially measured on HREM. RESULTS: Forty patients were included (11 tailored versus 29 non-tailored). There were no differences in patient age (p = 0.6491) or BMI (p = 0.0677). Myotomy lengths were significantly longer for tailored compared to non-tailored overall (16.6 ± 2.2 versus 13.5 ± 1.8; p < 0.0001), and for only type III achalasia (15.9 ± 2.4 versus 12.7 ± 1.2; p = 0.0453), likely due to more proximal starting position in tailored cases (26.0 ± 2.2 versus 30.0 ± 2.7; p < 0.0001). Procedure success (Eckardt < 3) was equivalent across groups overall (p = 0.5558), as was postoperative Eckardt score (0.2 ± 0.4 versus 0.8 ± 2.3; p = 0.4004). Postoperative Eckardt score was significantly improved in the tailored group versus non-tailored for type III only (0.2 ± 0.4 versus 1.3 ± 1.5; p = 0.0435). A linear correlation was seen between increased length and greater improvement in Eckardt score in the non-tailored group (p = 0.0170). CONCLUSIONS: Using HREM to inform surgeons of the proximal location of the diseased segment resulted in longer myotomies, spanning the entire affected segment in type III achalasia, and in lower postoperative Eckardt scores. Longer myotomy length is often more easily achieved with POEM than with Heller myotomy, which raises the question of whether POEM results in better outcomes for type III achalasia, as types I and II do not generally have measurable spastic segments.

Treatment of Achalasia with Per-Oral Endoscopic Myotomy: Analysis of 50 Consecutive Patients.

BACKGROUND: Peroral endoscopic myotomy (POEM) has become an acceptable incisionless treatment for achalasia based on encouraging outcomes in multiple series worldwide. This report reflects our early experience. METHODS: Data were collected prospectively on all patients undergoing POEM between June 2011 and April 2016 under IRB approval. Diagnosis of achalasia was confirmed by standard preoperative work-up. Primary outcome was symptom relief, measured by Eckardt score. Secondary outcomes were operative time, length of stay (LOS), adverse events, failure, and recurrence. RESULTS: Fifty patients were included; 30 were female. Mean age was 55.7 ± 17.7 years. Mean BMI was 29.5 ± 9.2. Median OR time was 133.5 minutes (range 70-462); average myotomy was 13.1 ± 2.3 cm. One early case was converted to a laparoscopic Heller myotomy due to extensive submucosal fibrosis from a recent Botox injection. Two cases were aborted; one due to extensive submucosal fibrosis and the other to intraoperative capnopericardium. Median LOS was 1 day (range 0.8-8). Two major complications occurred: intraoperative cardiac arrest due to capnopericardium and postoperative submucosal hemorrhage. There were no deaths. Mean postoperative Eckardt score was 1.0 ± 1.9 (range 0-8) at 2-6 weeks (vs. preoperative score 7.7 ± 2.8; P < .0001); mean dysphagia component 0.35 ± 0.28 (vs. preoperative score 2.6 ± 0.7; P < .0001). Two recurrences were identified, both at 6 months. CONCLUSIONS: POEM is a safe and durable treatment for achalasia in the short term. We demonstrated marked improvement of symptoms in all completed cases. There was an acceptable serious adverse event rate of 4%, failure of 6% due to patient selection, and recurrences occurring in only 4% of cases.

Comparison of peritoneal closure versus non-closure in laparoscopic trans-abdominal preperitoneal inguinal hernia repair with coated mesh.

BACKGROUND: Peritoneal closure during laparoscopic trans-abdominal preperitoneal (TAPP) inguinal hernia repair has been the standard of care to prevent bowel obstruction due to adhesions generated by contact with mesh. However, with newer coated meshes, leaving the peritoneal layer open may be safe. While many studies compare methods of peritoneal flap closure, there is a deficit of literature reporting the outcomes of non-closure. METHODS: A retrospective comparison of peritoneal flap closure versus non-closure during primary laparoscopic TAPP inguinal hernia repair with coated mesh was performed for all patients at Baystate Medical Center meeting inclusion criteria between January 2005 and August 2016. Primary outcome was any procedure-related adverse outcome following repair. Secondary outcomes included operative time, resolution of pre-operative pain and/or gastrointestinal symptoms, and hernia recurrence. RESULTS: Of 231 patients, 55 (24%) underwent peritoneal flap closure and 176 (76%) underwent non-closure. Demographic, comorbidity, and hernia characteristics were comparable between groups with the exception of obesity (p = 0.01), current smoking status (p = 0.05) and hernia side [p = 0.04 (left), 0.0003 (right)]. Mean operative time was higher in the closure group than non-closure (98.1 ± 37.1 min vs. 76.8 ± 32.9, p < 0.0001). No cases were converted to open. Average follow-up was 21.6 ± 23.8 months. Ninety-three percent of closure patients had documented resolution of pre-operative pain versus 94.0% of non-closure (p = 0.81). The closure group experienced a higher percentage of post-operative complications, though this did not reach significance (5.5 vs. 2.3%; p = 0.36). Compared to the closure group, the non-closure groups experienced similar post-operative pain (3.6 vs. 1.2%; p = 0.24) and recurrence rate (1.8 vs. 4.0%; p = 0.68). There were no bowel obstructions, surgical site infections, unplanned readmissions, or unplanned re-operations. CONCLUSIONS: Equivalent patient outcomes were seen for both procedure types post-operatively and during follow-up. Operative times were significantly shorter for non-closure patients. Larger study population and longer follow-up is necessary to evaluate true long-term complication rates in flap non-closure.

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.

The NOVEL trial: natural orifice versus laparoscopic cholecystectomy-a prospective, randomized evaluation.

INTRODUCTION: The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy. METHODS: Ninety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes. RESULTS: There were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p = 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p < 0.05). CONCLUSION: The safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.

A case report of unexpected pathology within an incarcerated ventral hernia.

INTRODUCTION: Incidence of hernial appendicitis is 0.008%, most frequently within inguinal and femoral hernias. Up to 2.5% of appendectomy patients are found to have Crohn's disease. Elucidating the etiology of inflammation is essential for directing management. PRESENTATION OF CASE: A 51-year-old female with achondroplastic dwarfism, multiple cesarean sections, and subsequent massive incisional hernia, presented with ruptured appendicitis within her incarcerated hernia. She underwent diagnostic laparoscopy, appendectomy, intra-abdominal abscess drainage, and complete reduction of ventral hernia contents. She developed a nonhealing colocutaneous fistula, causing major disruptions to her daily life. She elected to undergo hernia repair with component separation for anticipated lack of domain secondary to her body habitus. Her operative course consisted of open abdominal exploration, adhesiolysis, colocutaneous fistula repair, ileocolic resection and anastomosis, and hernia repair with bioresorbable mesh. She tolerated the procedure well. Unexpectedly, ileocolic pathology demonstrated chronic active ileitis, diagnostic of Crohn's disease. DISCUSSION: Only two cases of hernial Crohn's appendicitis have been reported, both within Spigelian hernias. Appendiceal inflammation inside a hernia sac may be attributed to ischemia from extraluminal compression of the hernia neck. This case demonstrates a rare presentation of multiple concurrent surgical disease processes, each of which impact the patient's treatment plan. CONCLUSION: This is the first report of incisional hernia appendicitis with nonhealing colocutaneous fistulas secondary to Crohn's. It is a lesson in developing a differential diagnosis of an inflammatory process within an incarcerated hernia and management of the complications related to laparoscopic hernial appendectomy in a patient with undiagnosed Crohn's disease.

Ramifications of single-port laparoscopic surgery: measuring differences in task performance using simulation.

INTRODUCTION: Single-port laparoscopic surgery imposes unique psychomotor challenges. We used surgical simulation to define performance differences between surgeons with and without single-port clinical experience and examined whether a short course of training resulted in improved performance. METHODS: Study participants were assigned to 3 groups: resident group (RES), experienced laparoscopic surgeons with (SP) and without (LAP) prior single-port laparoscopic experience. Participants performed the Fundamentals of Laparoscopic Surgery precision cutting task on a ProMIS trainer through conventional ports or with articulating instruments via a SILS Port (Covidien, Inc). Two iterations of each method were performed. Then, 6 residents performed 10 successive single-port iterations to assess the effect of practice on task performance. RESULTS: The SP group had faster task times for both laparoscopic (P = .0486) and single-port (P = .0238) methods. The LAP group had longer path lengths for the single-port task than for the laparoscopic task (P = .03). The RES group was slower (P = .0019), with longer path length (P = .0010) but with greater smoothness (P = .0186) on the single-port task than the conventional laparoscopic task. Resident performance task time (P = .005) and smoothness (P = .045) improved with successive iterations. DISCUSSION: Our data show that surgeons with clinical single-port surgery experience perform a simulated single-port surgical task better than inexperienced single-port surgeons. Furthermore, this performance is comparable to that achieved with conventional laparoscopic techniques. Performance of residents declined dramatically when confronted with the challenges of the single-port task but improved with practice. These results suggest a role for lab-based single-port training.