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Background: A safe technique is essential for successful access site closure in Natural Orifice Translumenal Endoscopic Surgery (NOTES) and for closures of iatrogenic perforations. Aim: To compare an over-the-scope clip (OTSC) versus an endoloop + endoclips closure technique (KING closure). Methods: 40 minipigs underwent NOTES peritoneoscopy with liver biopsy. Gastrotomies and rectotomies were closed with OTSC ( n = 20; 10× stomach, 10× rectum) or KING closure ( n = 20; 10× stomach, 10× rectum). The animals were euthanized 28 days after the procedure. The main outcome variables were technical feasibility, effectiveness, and healing. Results: Stomach: All but one closure (KING) was successfully completed. The times of closure were similar between the techniques. At necropsy, all access sites were healed. In two animals (1× KING, 1× OTSC), an abscess, probably related to the closure technique, was found. Histologically, transmural healing with muscular bridging was observable in nine pigs for KING versus two pigs for OTSC closure ( p = 0.003). Inflammation was present in three pigs for KING versus seven pigs for OTSC closure ( p = 0.08). Rectum: All closures were successfully completed. The times of closure were similar between the techniques. At necropsy, all closure sites had healed. Transmural healing with muscular bridging was present in nine pigs for KING versus two pigs for OTSC closure ( p = 0.003). Inflammation was present in two pigs for KING versus seven pigs for OTSC closure ( p = 0.03). In one animal (OTSC), an enterocolic fistula developed in the proximity of the closure site. Conclusions: OTSC and KING closure are comparable closure techniques in terms of technical feasibility and effectiveness. KING closure provides a superior histological outcome compared with OTSC closure. [ABSTRACT FROM AUTHOR]

Background: A highly reliable and safe means of gastric closure for natural orifice transluminal endoscopic surgery (NOTES) has yet to be developed. The authors have previously described the self-approximating transluminal access technique (STAT) as a means for gastrotomy closure in transgastric surgery. It has yet to be determined whether biologic mesh can be utilized in facilitating gastrotomy closure via STAT. The aim of this study was to determine the feasibility of implanting an acellular porcine dermal matrix (LifeCell) into the STAT tunnel and investigate whether it will become incorporated into the submucosal plane of the STAT tunnel. Methods: Five pigs underwent transgastric left uterine horn resection utilizing STAT. For closure, the acellular porcine dermal matrix was implanted within the submucosal plane, occluding the seromuscular incision. The mucosal incision was then closed over the matrix with endoscopically placed clips. Necropsy was performed after a 3 week survival period. Histopathological evaluation of the tunnel and matrix was performed. Results: The matrix was successfully implanted in all five animals. Average OR time was 151 ± 68 min. Average time to anchor and embed the matrix within the tunnel was 4 ± 1 and 9 ± 12 min, respectively. There was one duodenal perforation related to a balloon occlusion device. Postoperative course was unremarkable; the average weight gain at 3 weeks was 22 ± 5 lbs. On necropsy, one animal had some protrusion of the matrix at the serotomy, with adhesions to small bowel and liver. Histopathology revealed one clinically insignificant microabscess but otherwise demonstrated local inflammation and fibrovascular ingrowth into the matrix. Conclusions: The porcine dermal matrix can be successfully implanted within the gastric submucosal plane and evidence of incorporation into the gastric wall by 3 weeks was demonstrated. [ABSTRACT FROM AUTHOR]

Background: A reliable method for gastrotomy closure in NOTES will be essential for NOTES to become viable clinically. However, methods using existing and widely available endoscopic accessories have been ineffective. The objective of this study was to evaluate the feasibility and safety of a new simple method for gastric closure (retracted clip-assisted loop closure) that uses existing endoscopic accessories with minor modifications. Methods: The retracted clip-assisted loop closure technique involves deploying 3-4 Resolution clips (modified by attaching a 90-cm length of suture to the end of each clip) along the margin of the gastrotomy with one jaw on the serosal surface and the other jaw on the mucosal surface. The suture strings are threaded through an endoloop. Traction is then applied to the strings causing the gastric wall to tent. The endoloop is secured below the tip of the clips, completing a full-thickness gastrotomy closure. The main outcome measures were feasibility, efficacy, and safety of the new retracted clip-assisted loop closure technique for NOTES gastrotomy closure. Results: An air-tight seal was achieved in 100% ( n = 9) of stomachs. The mean leak pressure was 116.3 (±19.4) mmHg. Conclusions: The retracted clip-assisted loop closure technique can be used to perform NOTES gastrotomy closure by using existing endoscopic accessories with minor modifications. [ABSTRACT FROM AUTHOR]

Closure of access site is one of the key issues that will determine the development of natural orifice transluminal endoscopic surgery. Our study was designed to compare the effectiveness of gastrotomy closure using endoloop and endoclip with hand-sewn closure as a control. Gastrotomy was carried out on 24 ex vivo porcine stomachs and the gastrotomies were randomized to be closed with either hand-sewn, endoloop or endoclip techniques. A 2 cm gastrotomy was created with a needle knife and sphincterotome and the defects closed thereafter. We measured the time to closure of gastrotomy and the pressure at which the closure leaked. Three endoloops were required for all the closures in the endoloop group. In the endoclip group, the mean (range) number of endoclips used was 10 (8-13). There was no difference in the median closure times between endoloop 28 (16-58) min and endoclip 30 (21-40) min; however, time for hand-sewn closure was much shorter (3-5 min). All stomachs were successfully distended with air without leak at the end of the procedure and none experienced fluid leak. The endoclip closure endured a significantly higher median (range) pressure of 72.5 mmHg (15-80 mmHg) before leaking compared to that of an endoloop 25 mmHg (15-37 mmHg) ( P < 0.001). The hand-sewn gastrotomy leaked at pressure of 95 mmHg (75-130 mmHg). The majority of air leaks were from the wound site. In the endoclip group, two leaks were noted at the clip bite site. In a bench-top model, endoclips seem to be better for gastrotomy closure because of their potential to endure relatively higher pressure without any prolongation of application time. Animal survival studies are needed to explore technical and wound-closure-related problems arising as a result of use of endoclips and endoloops for gastrotomy closure. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM PUBLISHER]

Background: Experimental studies investigating transgastric endoscopic surgery report closure of the gastric wall incision with clips. The author of this report describes endoloop placement as an alternative, equally efficient, faster method for gastrotomy closure.Methods: Eight female pigs with a mean weight of 30 kg were used. Abdominal endoscopic exploration and transgastric operations including hepatic biopsies, bilateral tubal ligation, cholecystectomy, and closure of the gastrotomy were performed. The experiment was divided into two parts. The first part included five animals, which were killed immediately after the procedure. The second part included five animals, which were kept alive and killed 15 to 20 days later.Results: The first part of the experiment, performed for technical skills acquisition, involved transgastric abdominal exploration, liver biopsies, and bilateral tubal ligation, which were successful for all five animals. The gastric wall incision was closed by applying clips in four animals and endoloops in one animal. During the autopsy at the end of the experiment, the sites of intervention were examined macroscopically. In the second part of the experiment, gastrotomy closure with endoloop application was performed in two animals and with clip application in one animal. All three animals survived, gained weight, and demonstrated no signs of infection. They were killed 15 to 20 days after the procedure, and no signs of intraabdominal infection were found. Cultures from the peritoneal cavity were negative. At necropsy, macroscopic and microscopic examination confirmed complete healing of the gastrotomy.Conclusions: Transgastric endoscopic surgery is technically feasible and effective. The application of endoloops for closure of the gastric opening is a fast, easy, and equally safe alternative to clip placement. [ABSTRACT FROM AUTHOR]

Background: The transgastric approach is currently being studied as a potentially less invasive alternative to conventional laparoscopy for intra-abdominal surgery. A major obstacle to overcome is the closure of the transgastric incision in a rapid, reproducible, and safe manner. The effectiveness of various techniques for gastrotomy closure were compared by assessing leak pressures in an ex vivo porcine stomach model.Methods: Whole stomachs from adult white pigs were suspended in a Plexiglas box to facilitate endoscopic technique. Standard gastrotomies were made by needle knife incision and dilation with a controlled radial expansion (CRE) balloon. The first arm used standard QuickClips; the second, a prototype device developed by LSI Solutions; the third, hand-sewn by a senior surgeon; the final, a control with open gastrotomy. Five stomachs were tested per study arm. After closure, each stomach was inflated by an automated pressure gauge. The pressures to achieve air leakage and liquid leakage were recorded.Results: The unclosed controls demonstrated air leakage at a median pressure of 15 mmHg, representing baseline system resistance. The QuickClip closures leaked air at a median pressure of 33 mmHg. The prototype gastrotomy device yielded the highest median air leak pressure of 85 mmHg while dramatically diminishing time for incision and gastrotomy closure to approximately 5 min. The hand-sewn closures leaked air at a median pressure of 47 mmHg. Using Kruskal-Wallis statistical analysis, the comparisons were significant (p = 0.0019). Post hoc paired comparisons using MULTTEST procedure with both Bonferroni and bootstrap adjustments revealed that the difference between prototype and clips was significant; prototype versus hand-sewn was not. Liquid-leak pressures produced similar results.Conclusions: The prototype device decreases procedure time and yields leak-resistant gastrotomy closures that are superior to clips and rival hand-sewn interrupted stitches. [ABSTRACT FROM AUTHOR]