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.

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.

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.

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.

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.

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.

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.

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.

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.

NOTES(®) stapled cystgastrostomy: a novel approach for surgical management of pancreatic pseudocysts.

BACKGROUND: Traditional approach for surgical management of mature pancreatic pseudocysts is by internal surgical drainage. Endoscopic drainage procedures have also been described. We describe Natural Orifice Translumenal Endoscopic Surgery (NOTES(®)) stapled cystgastrostomy as a less invasive surgical procedure. STUDY DESIGN: Case series. METHODS: NOTES(®) cystgastrostomy was performed in six patients with mature pseudocysts from June 2007 to July 2009 under institutional review board (IRB) protocol. The size of the pseudocysts varied from 8 to 23 cm, and all of the pseudocysts were considered complex pseudocysts. The operative team included two general surgeons and a gastroenterologist. The procedure included endoscopic ultrasound (EUS)-guided puncture of the stomach just below the gastroesophageal (GE) junction to gain access to the pseudocyst, guidewire placement, and then dilatation with a balloon to 18-20 mm. Endoscopic necrosectomy and debridement were performed when possible, followed by transoral surgical anastomosis under endoscopic visualization with the SurgAssist™ SLC 55 (Power Medical Interventions, Langhorne, PA) 4.8-mm stapler. Anastomotic length varied from 5.5 to 8 cm. In one patient, diagnostic laparoscopy was performed after the procedure due to inadvertent pneumoperitoneum; no leak or perforation was identified. RESULTS: Length of stay varied between 2 and 14 days. All patients had routine esophagogastroduodenoscopy (EGD) at 1 and 6 weeks postoperatively to evaluate patency; computed tomography (CT) scan was done at 2-3 months to demonstrate resolution of the pseudocyst. All patients had significant decrease in pseudocyst size with patent anastomosis on postoperative EGD, although one patient required endoscopic anastomotic dilatation due to continued symptoms 6 weeks after the operation. Her pseudocyst completely resolved 4 months postoperatively. An additional patient required subsequent distal pancreatectomy due to recurrent symptoms of chronic pancreatitis. CONCLUSION: NOTES(®) cystgastrostomy is comparable to previously described surgical approaches, yet is as minimally invasive as endoscopic drainage procedures previously described for management of pseudocysts. It is less invasive than laparoscopic or open cystgastrostomy, yet provides definitive treatment.

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.

Gastric transmural pressure measurements in vivo: implications for natural orifice transluminal endoscopic surgery (NOTES).

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Forces that might be exerted on the gastric wall to disrupt closure have not been measured in humans or animals. OBJECTIVE: To determine how transmural gastric pressure gradients vary under different experimental conditions. DESIGN: In vivo porcine model. SETTING: Animal laboratory. PATIENTS: Eleven laboratory pigs. INTERVENTIONS: Pressure transducers were placed in the abdomen and stomachs of the test animals. Simultaneous pressure measurements were obtained to determine the stresses applied to the gastric wall during various maneuvers. MAIN OUTCOME MEASUREMENTS: Continuous intra-abdominal and intragastric pressures in vivo. Transgastric pressure gradients (DeltaP) were computed in real time by subtracting gastric pressure from abdominal pressure. RESULTS: In all cases, the measured gastric pressures were nearly identical to those measured in the abdominal cavity because the stomach is entirely contained within the abdomen. The transmural gastric pressure gradients were near zero during a variety of experimental conditions. LIMITATION: Anesthetized animal model, not engaged in usual activities. Relatively low pressures generated during a cough sequence and a Valsalva maneuver compared with reported values in the literature. CONCLUSION: Estimates of gastric pressures that must be tolerated by gastric closure devices after natural orifice transluminal endoscopic surgery procedures have been greatly overestimated. Absolute gastric pressure is counteracted by external (intra-abdominal) pressure such that the net transmural gastric pressure gradient remains near zero under a variety of conditions.

Single-port laparoscopic cholecystectomy: initial experience.

BACKGROUND: As surgeons embrace the concept of increasingly less invasive surgery, techniques using only a single small incision have begun to gain traction. Several commercially available products have emerged recently. The TriPort system and the SILS Port are single-port devices that allow the surgeon to perform laparoscopic surgery through a 2- to 3-cm periumbilical incision. This study aimed to ascertain whether these devices allow safe and reliable access for laparoscopic cholecystectomy. METHODS: From March 2008 to June 2009, single-port laparoscopic cholecystectomy was attempted for 22 patients with an average age of 40 years (range, 23-73 years). The data collected prospectively after institutional review board approval included demographics, operative time, complications, and reasons for conversion to standard four-port laparoscopic surgery. RESULTS: The operation was completed successfully for 21 of the 22 patients (15 women and 7 men) using five different techniques. The mean body mass index (BMI) of the patients was 32.7 kg/cm(2) (range, 22.3-46.1 kg/cm(2)). Three of the patients had previously undergone laparoscopic Roux-en-Y gastric bypass. The mean operative time was 80.8 min (range, 51-156 min). One patient experienced a Richter's hernia postoperatively, which required a reoperation and subsequent bowel resection. One patient required conversion to a standard four-port laparoscopic cholecystectomy because the articulating instrument could not reach the gallbladder from the umbilicus. CONCLUSION: The results from the current series show single-port laparoscopic cholecystectomy to be a promising technique. A variety of patient demographics appear suited to this approach. The operative time in this series compares favorably with that for the standard four-port operation. The feasibility of single-port laparoscopic cholecystectomy is now established. However, routine application of this novel technique requires an evaluation of its safety and cost effectiveness in larger studies. In addition, its superiority over standard laparoscopic cholecystectomy in terms of postoperative pain, cosmesis, and overall patient satisfaction requires further study. Refinements in instrumentation will enable wider use of this novel minimally invasive approach.

Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.

INTRODUCTION: Transgastric NOTES(®) procedures remain without a simple method to close the gastrotomy. In four survival swine studies, we have tested a novel gastric closure device: the loop-anchor purse-string (LAPS) closure system. METHODS: In four anesthetized pigs, an endoscopic gastrotomy was performed. Four loop anchors were arrayed in a 2-cm square pattern around the gastrotomy. The endoscope was passed into the abdominal cavity, and the gastrotomy was cinched closed. RESULTS: Procedure times ranged from 50-180 minutes. Three pigs survived 14 days. One animal was sacrificed early due to signs of sepsis. Another animal developed fevers and was treated with antibiotics. At necropsy, there were no abscesses, including in the septic animal. Histologic examination revealed evidence of healing in all animals. DISCUSSION: The LAPS system holds promise with early success in an animal model. Future human studies are needed to determine viability as a human visceral closure device.

Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures.

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Few tests of the integrity of these closures have been published. OBJECTIVE: To determine whether a gastrotomy can be closed safely and effectively from within the stomach by using looped T-anchors-a novel, endoscopically placed device. DESIGN: Head-to-head comparison trial of 2 closure methods in 9 explanted porcine stomachs. SETTING: Animal laboratory. INTERVENTION: Paired gastrotomies were made in porcine explants. One was closed by using endoscopic clips, and the other was closed by using modified T-anchors in a purse-string fashion. MAIN OUTCOME MEASUREMENTS: Gastric transmural pressure gradients at bursting of these closures were measured while the explanted stomachs were inflated with a high-pressure insufflator. RESULTS: The mean burst pressure of the looped T-anchors was 27.3 mm Hg, whereas that of the clip closures was 14 mm Hg. By using 10 mm Hg as a threshold for a "secure" closure, 7 of 9 clip closures failed to meet the threshold value, whereas all 9 of the T-anchor closures met or exceeded the threshold value (P = .0023, 2-tailed Fisher exact test). LIMITATION: Nonsurvival study. CONCLUSION: Looped T-anchors provide a secure gastric closure for natural orifice surgery and are superior to endoscopic clips for this purpose.