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Background and Aims: The risk of bleeding and thromboembolic events in patients undergoing peroral endoscopic myotomy (POEM) who are receiving antithrombotic therapy is unknown. Our primary aim was to assess the safety of POEM in this patient subset. Secondary outcomes were rates of clinical success, GERD, and procedure-related outcomes., Methods: This was an international, 1:1, case-control study performed at 10 centers using prospectively maintained databases. All consecutive patients who underwent POEM before November 2019 were considered for inclusion. Cases were patients on antiplatelet and/or anticoagulant therapy. Controls not receiving antithrombotics were matched for age and esophageal motility disorder. Primary outcomes were major bleeding and thromboembolic events on postprocedural day 30., Results: Of 2895 patients who underwent POEM, 126 cases (103 on antiplatelets, 35 anticoagulants, 12 both) and 126 controls were enrolled. The rate of major bleeding was higher for the antithrombotics users (5.6% vs 0.8%, P = .03). Anticoagulants and clopidogrel were temporarily interrupted in all cases. Aspirin was continued in 40.5% of users without increasing the bleeding risk. One thromboembolic event occurred in each group (0.79%; P = 1.00). No POEM-related deaths were noted. Rates of clinical success (91.7% vs 96% in controls, P = .20), postprocedural GERD, and technical-related outcomes were similar in both groups. Antithrombotic management was heterogeneous, and guidelines were not adhered to in 23.8% of cases., Conclusions: POEM is safe and effective in patients receiving antithrombotic therapy although it is associated with a greater risk of major bleeding., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Endoscopic insufflation has been associated with marked increase in intra-abdominal pressure (IAP) and hemodynamic and respiratory changes during transgastric surgery., Objective: To investigate the hemodynamic and respiratory effects during intraperitoneal cavity exploration through 3 different natural orifice transluminal endoscopic surgery (NOTES) access locations compared with laparoscopy., Design and Setting: Survival experiments using 40 female pigs randomized to transgastric, transcolonic, transvaginal, and laparoscopic peritoneoscopy., Interventions: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation was used in NOTES with a maximum pressure of 14 mm Hg. In the laparoscopy group, the IAP was maintained at 14 mm Hg. NOTES procedures were performed by an endoscopist (with the assistance of a gynecologist in the transvaginal group and a second endoscopist in the transgastric and transrectal groups) and laparoscopy by 2 surgeons., Main Outcome Measurements: Invasive hemodynamic and respiratory data. Blood samples were drawn for gas analyses., Results: All experiments except one in the transrectal group were completed. The IAP was significantly lower in all NOTES groups compared with the laparoscopy group. A significant increase in mean systemic arterial blood pressure was observed in the laparoscopy group at 15 and 30 minutes of intraperitoneal cavity exploration, but it remained unchanged during all NOTES procedures. An increase in airway pressures was observed at 15 and 30 minutes of peritoneoscopy in the animals undergoing laparoscopy, whereas those parameters remained unchanged in the NOTES groups. The laparoscopy group showed a significant impairment in pulmonary gas exchange (decrease in Pao(2), increase in Paco(2), and decrease in arterial pH) after 30 minutes of peritoneoscopy, whereas only a slight increase in Paco(2) was observed in the transrectal and transvaginal groups., Limitations: Healthy animal model., Conclusion: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation can minimize the risk of hemodynamic and respiratory compromise caused by acute changes in IAP., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Aim: The aim of this study was to evaluate the restoration of gastrointestinal motility after NOTES using capsule endoscopy (CE)., Materials and Methods: Twenty adult Yorkshire pigs were randomly assigned to four groups: transgastric NOTES (gNOTES), transrectal NOTES (rNOTES), transvaginal NOTES (vNOTES), and laparoscopy (LAP). At the end of a 30-min peritoneoscopy with identification of seven predetermined organs, an array of eight receivers and the recorder were attached to the abdominal wall. The CE was delivered into the antrum with the help of an endoscope and a polypectomy snare. Animals were kept alive for 14 d., Results: Median time for surgery was longer in gNOTES (56 min, range 47-63) and vNOTES (54 min, range 44-79) than in LAP (32 min, range 32-33; P < 0.05 and P < 0.01) and in rNOTES (45.5 min, range 33-56) (P = ns). This increase was related to a larger incision and longer closure times. Images from the CE were successfully retrieved in 19 cases. The CE was retained in the stomach in all animals in gNOTES (459 min; range 360-600), but only in one animal in rNOTES and vNOTES and in none in the LAP group. Failure of passage of the CE beyond the stomach was associated with gNOTES and longer closure of the incision. Animals in the gNOTES group gained less weight than the others and this change was statistical significant when compared with vNOTES animals (1.7 kg, range -1.98 to 4.5 versus 8.4 kg, range 5.8 to 11.45; P < 0.01)., Conclusion: Gastric emptying is delayed after gNOTES peritoneoscopy compared with rNOTES, vNOTES, and LAP and this effect is associated with less weight gain., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Inflammatory changes of different NOTES approaches remain unknown. The aim of this study was to compare the inflammatory effects of NOTES and laparoscopy., Methods: Forty female pigs were assigned to transgastric, transrectal, and transvaginal NOTES and laparoscopic peritoneoscopy groups. Antiseptic technique was utilized for NOTES whereas laparoscopy was performed sterile. Intraperitoneal pressures were monitored and maintained below 15 mmH(2)O. Pneumoperitoneum was maintained with CO(2) in all groups. Pre- and postoperative blood samples of IL-6, Il-1β, and TNFα, and peritoneal fluid collected at surgery were analyzed. Animals were followed daily for 14 days. At necropsy, peritoneal fluid was collected for cytokine analysis., Results: Thirty-nine peritoneoscopies were successfully completed. The median procedure time was longer in the NOTES groups (57 min, range = 33-109) than in the laparoscopy group (33 min, range 32-36; P < 0.001); this was related to longer incision time and closure time. All 39 completed follow-up. Severe bleeding in the post-transrectal approach required early sacrifice of the remaining animal. Besides this, complications were similar among groups. At necropsy, adhesions were seen in four animals in the gastric group, five in the rectal group, two in the vaginal group, and two in the laparoscopic group (P = ns). There were no statistical differences in serum levels of TNFα among the groups. When serum TNFα values were expressed as the difference from the baseline, in the transvaginal group they were significantly lower than in the transrectal at 2 h [0.5 pg/ml (range = -14 to 59) vs. 60 pg/ml (range = -8 to 303); P = 0.041] and at 8 h [-5.5 pg/ml (range = -86 to 55] vs. 37 pg/ml (range = -30 to 62); P = 0.031]. The limitations of this study were that the analyses of IL-6 and Il-1β were not possible because most of the samples were below detectable levels, it was an animal model, and the sample size was small., Conclusion: Inflammatory parameters are similar between NOTES and laparoscopic peritoneoscopy despite longer surgery time in the NOTES group. The vaginal route seems to reduce the inflammatory stress.

Background: Infection in natural orifice transluminal endoscopic surgery (NOTES) remains controversial., Objective: To estimate the frequency of infection during NOTES peritoneoscopy with different routes of access and to compare with laparoscopy., Design: Prospective randomized controlled study (Canadian Classification type I)., Methods: Forty female pigs were randomly assigned to 3 NOTES (transgastric, transrectal, and transvaginal) and laparoscopic groups. Antiseptic technique was used for NOTES, whereas laparoscopy was performed in a sterile environment. Preoperative and postoperative intravenous antibiotics were administered. Closure of the transluminal access site was performed in all animals. Peritoneal fluid was collected for culture at the end of surgery and at necropsy at day 14., Results: Thirty-nine peritoneoscopies were successfully completed. Necropsy confirmed complete healing of NOTES incisions, but 2 animals in the laparoscopy group had small abscesses in the abdominal incisions. There were no statistical differences in the presence of peritoneal adhesions. Positive culture results were seen in all groups at the end of the procedure and in all animals at necropsy, but this did not lead to clinical signs of gross infection. The most common organisms that colonized the peritoneum were gram-positive cocci and gram-negative bacilli from the normal swine gastrointestinal flora., Limitations: Animal model and small sample size., Conclusions: In these small series of animals and with the careful lavage and preparation used, NOTES appeared to be comparable to laparoscopy in terms of peritoneal contamination and clinical infection. Despite the adherence to a strict antiseptic protocol, peritoneal contamination occurs but does not lead to septic complications in the swine., (Copyright © 2011 AAGL. Published by Elsevier Inc. All rights reserved.)

Background: Secure closure of the colonic access site is one of the most important issues for the development of natural orifice transluminal endoscopic surgery., Objective: To evaluate the feasibility, reproducibility, and efficacy of a new over-the-scope clip., Design: Descriptive study, in vivo porcine colon., Intervention: In 10 female Yorkshire pigs weighing 30 to 35 kg, a 10-mm colotomy was performed by using a needle-knife and advancing the endoscope to the peritoneal cavity. Colonic closure was performed by using the Padlock-G clip (Aponos Medical, Kingston, NH) delivered with the Lock-It system (Aponos)., Main Outcome Measurements: Animals were monitored daily for signs of peritonitis and sepsis over a period of 14 days. During necropsy, the peritoneal cavity was examined, and the colon segment containing the incision was excised for pathological study., Results: Closure was achieved in all cases. Nine of 10 pigs survived 14 days without complications, but 1 pig was killed immediately after the procedure because of severe bleeding during the colonic incision. The median closure time was 8 minutes (range 1-30 minutes). At necropsy, adhesions were observed in 5 cases. The incision was hardly visible at the serosa side in 3 cases and was not identified in 6 cases. In 6 cases, the clip was still slightly attached to the mucosa, and it was not found in 3 cases. The pathological study revealed a complete remodeling of the colonic wall in all cases., Limitations: Animal model, noncomparative study., Conclusion: The Padlock-G clip procedure is feasible, reproducible, effective, and easy to perform, and it provides a reliable colonic closure., (Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)