Efficacy of the over-the-scope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas

Background

Colorectal postsurgical leaks and fistulas are severe complications that dramatically increase morbidity and mortality. The aim of this study was to evaluate the clinical impact of over-the-scope clip (OTSC) closure to seal the visceral wall in the management of acute and chronic colorectal postsurgical leaks and fistulas.

Methods

We reviewed our prospective series of acute and chronic colorectal postsurgical leaks and fistulas observed between April 2008 and September 2011 and treated by OTSC. Indications were all cases with an orifice <15?mm in maximum diameter with no extraluminal abscess and luminal stenosis.

Results

Endoscopic OTSC closure was performed in 14 consecutive patients (mean defect?=?9.1?mm in diameter) by means of 10.5- or 12-mm clips, depending on the wall defect diameter. In eight cases, the indication was an acute leak and in six cases a chronic leak, mainly after anterior rectal resection; two cases were complicated by a rectovaginal fistula and in two other cases by a colocutaneous fistula. OTSC treatment was used to complete endoscopic vacuum-assisted closure of a large defect in three cases. The overall success rate was 86?% (12/14): 87?% (7/8) in acute and 83?% (5/6) in chronic cases. No OTSC-related complications occurred. Further surgery was required in one case.

Conclusion

Endoscopic OTSC closure of colorectal postsurgical leaks and fistulas is a safe technique, with a high success rate in both acute and chronic cases, including rectovaginal and colocutaneous fistulas.     

The Over-The-Scope-Clip (OTSC) System is Effective in the Treatment of Chronic Esophagojejunal Anastomotic Leakage

Introduction

Management of postoperative esophagojejunal anastomotic leakage after total gastrectomy represents a very challenging event. Surgical repair is difficult, and conservative treatment can predispose to more severe complications. Endoclips and self-expanding stents are useful endoscopic therapeutic options but present some drawbacks. The Over-The-Scope-Clip (OTSC) system has been shown to be appropriate to close acute small gastrointestinal perforations, but its use in the treatment of chronic leakage remains controversial.

Case Series

The present series reports three consecutive chronic esophagojejunal anastomotic leaks successfully treated with OTSC. In all cases, clip application was simple, safe and effective, without early and late complications.

Discussion

The OTSC system may represent a new therapeutic option in the management of postoperative esophagojejunal anastomotic leakage.     

Comparing over-the-scope clip versus endoloop and clips (KING closure) for access site closure: a randomized experimental study

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.     

Management of non-acute gastrointestinal defects using the over-the-scope clips (OTSCs): a retrospective single-institution experience

Introduction

Advanced endoscopic techniques provide novel therapies for complications historically treated with surgical interventions. Over-the-scope clips (OTSCs) have recently been shown to be effective at endoscopic closure of gastrointestinal (GI) defects. We hypothesize that by following classic surgical principles of fistula management, a high rate of long-term success can be achieved with endoscopic closure of non-acute GI tract defects.

Methods

A retrospective review of a single-institution prospectively maintained database (2012–2015) of all patients referred for the management of GI leaks or fistulae who underwent attempted closure with the OTSC system (Ovesco, Germany) was performed. Acute perforations were excluded. The primary endpoint was long-term success defined by the absence of radiographic or clinical evidence of leak or fistula during follow-up. Patients were stratified by success or failure of OTSC closure and compared with Fisher’s exact and Mann–Whitney U tests.

Results

We identified 22 patients with 28 defects (22 fistulae and 6 leaks). Most patients were female (59 %) with a mean age of 54 years (±14), median BMI of 29, and prior bariatric procedure (55 %). Comorbidities included smoking history (68 %) and diabetes (23 %). The majority of defects were solitary (64 %), involved the upper GI tract (82 %), and had been present for >30 days (50 %). Multiple therapeutic interventions were necessary in 46 % of defects. There were no adverse outcomes related to OTSC placement or misfiring. Endoscopic adjuncts were used in 61 % of cases. Overall success rate was 82 % (100 % for leaks and 76 % for fistulae) at a median follow-up of 4.7 months (IQR 2.1–8.4 months). Predictors of success and failure could not be distinguished due to limited sample size.

Conclusions

Over-the-scope clips can be safely and effectively used in patients presenting with GI leaks and fistulae. Further research is required to characterize the determinants of long-term success and risk factors for failure.

     

Endoscopic Closure of Postoperative Gastrointestinal Leakages and Fistulas with the Over-the-Scope Clip (OTSC)

Background

In contrast to conventional Through-the-Scope Clips, the novel Over-the-Scope Clip (OTSC®) allows endoscopic full thickness closure of gastrointestinal leakages. The purpose of this study was to evaluate the efficacy and safety of the OTSC for the management of postoperative gastrointestinal leakages and fistulas.

Methods

We retrospectively reviewed a series of 14 consecutive patients with postoperative gastrointestinal leakages and fistulas who were treated by OTSC application.

Results

Nine OTSCs were used for upper GI tract leakages; five were used for colorectal leakages. Seventy-nine percent (11/14) of leakages were chronic (treated by OTSC later than postoperative day 14). In nine patients, other therapies preceded OTSC application. Median follow-up time was 5.5 months (range, 0.25–17). Primary technical success was achieved in all (14/14) patients. No adverse events related to the use of the OTSC device were noted. Three early recurrences were observed (two colonic fistulas, one esophageal anastomotic leakage), leading to a long-term success rate of 79 % (11/14). Leakage closure finally was achieved in these three patients by surgery or endoscopic vacuum therapy.

Conclusions

The OTSC system is an effective and safe method for the management of postoperative leakages and fistulas of the gastrointestinal tract. Its exact place in treatment algorithms of postoperative leakages will have to be determined.     

Clipping for endoscopic perforations: initial success but late complication requiring surgery

Introduction

This response discusses the article by Kim and colleagues entitled "endoscopic clip closure versus surgery for the treatment of iatrogenic colon perforations developed during diagnostic colonoscopy: a review of 115,285 patients". Iatrogenic colonoscopic perforation, although uncommon, implies serious management problems for endoscopists and surgeons. Nonoperative treatment currently is recommended under certain conditions, and endoscopic clips can primarily close iatrogenic perforations, helping to avoid surgery. Of the 27 colonoscopic perforation cases presented in the article by Kim and colleagues, 16 were managed by endoscopic clipping closure and 11 by primary surgery. Conservative treatment failed for three patients. Only perforation size obtained statistical significance among the nine variables contrasted between the 11 cases with primary surgery and the 13 cases with successful endoscopic clipping. The results for the three patients whose endoscopic closure failed are not reported.

Authors′ opinion

The authors of this letter think it would have been interesting if these three patients had been included in the analysis due to the high importance of discovering factors that can predict failure of endoscopic clipping for perforations.

Conclusions

To call attention to possible late complications requiring surgery even when initial conservative management of endoscopic perforation succeeds, the authors of this letter present a case of a colocutaneous (actually, sigmoid-scrotal) fistula in a patient 2 weeks after an apparently successful closure of colonoscopic perforation with an “over-the-scope” clip.     

Over-the-Scope Clip Application Yields a High Rate of Closure in Gastrointestinal Perforations and May Reduce Emergency Surgery

Background

Perforation of the gastrointestinal tract may cause various complications and may require emergency surgery, even in patients with significant comorbidities.

Methods

Seventeen consecutive patients with indication for surgery due to a visible gastrointestinal perforation were treated with OTSC application. In this study, cause of perforation, estimated size, location, rate of perforation closure, outcome and complications were reported.

Results

In 11 of 17 patients (64.7?%), OTSC application resulted in permanent closure of perforations, thus avoiding surgery. All 11 successful cases had smaller perforation lengths (5.5?±?1.9?mm, p?<?0.02), widths (3.7?±?0.9?mm) or area (21.1?±?9.1?mm²), had vital margins of perforations and 1.1?±?0.3 OTSC per patient were necessary. The six unsuccessful cases (35.3?%) showed larger perforation lengths (13.4?±?8.8?mm, p?<?0.02), widths (5?±?4.5?mm) and area (97.6?±?149?mm²), had necrotic or soft inflammatory margins and significantly more OTSC (2.3?±?0.5, p?=?0.018) were tried.

Conclusions

OTSC application yields a high rate of endoscopic perforation closure in patients with macroscopic gastrointestinal perforation, even in an emergency setting, representing an alternative to surgery, especially when the size of the lesion is not too large and when vital or solid perforation margins are expected.     

The Clinical Utility of Over-the-Scope Clip for the Treatment of Gastrointestinal Defects

Background

The over-the-scope clip (OTSC) is a novel endoscopic tool that enables non-surgical management of gastrointestinal (GI) defects. The aim of this study was to report our experience with OTSC for patients with GI defects.

Methods

A prospectively maintained IRB-approved institutional database was queried for all patients treated with OTSC from 2012 to 2015. Primary outcome was the clinical success of the OTSC for the individual indication. Secondary outcome was the number of additional procedures needed following OTSC.

Results

Fifty-one patients were treated with OTSC: upper GI (UGI) 30 and lower GI (LGI) 21. GI leak (n?=?24; UGI?=?12, LGI?=?12) and fistulae (n?=?17; UGI?=?8, LGI?=?9) were the most common indications. Overall success rate for the treatment of leaks was 59 % [UGI 66 % vs. LGI 33 % (p?=?0.1)]. A lower success rate (35 %) was noted for fistulae [UGI 62 % vs. LGI 0 % (p?=?0.001)]. Success rates for UGI perforation, bleeding, and stent anchoring indications were 75, 75, and 50 %, respectively. Additional endoscopic or surgical interventions following OTSC were indicated in 68.6 % of the patients.

Conclusions

OTSC appears to have additional value in treating UGI defects. However, lower success rates for LGI defects were noted, specifically for fistulae. Most patients require an additional endoscopic or surgical procedure after one OTSC application.

     

Endoscopic clip closure versus surgery for the treatment of iatrogenic colon perforations developed during diagnostic colonoscopy: a review of 115,285 patients

Background

Although the incidence of perforation after endoscopic procedures of the colon is low, the rising number of diagnostic colonoscopies could pose relevant health problems. Optimizing treatment may reduce the probability of severe complications. This study aimed to determine perforation frequency and the management of perforations that occurred during diagnostic colonoscopy.

Methods

A retrospective review of patient records was performed for all patients with iatrogenic colonic perforations after sigmoidoscopy/colonoscopy from 2000 to 2011 in three institutions of The Catholic University of Korea. The patients’ demographic data, endoscopic procedure information, perforation location, therapy, and outcomes along with different therapeutic strategies were recorded.

Results

In the 12-year period, a total of 115,285 diagnostic sigmoidoscopic/colonoscopic procedures were performed. A total of 27 perforations occurred. Sixteen patients underwent endoscopic clipping, of which three patients failed and were referred for surgery. Fourteen patients in total underwent surgery for perforation. Endoscopic clip closure was successful in 81 % of the patients. No perforation-related major morbidity or mortality occurred.

Conclusion

Endoscopic repair using clips can be effective for the treatment of colon perforations that occur during diagnostic colonoscopy.     

Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure: a porcine feasibility and survival study

Background

Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefits of this new minimally invasive technique. This study aimed to evaluate the feasibility and safety of a transgastric (TG) pure-NOTES procedure in a diagnostic setting.

Methods

A TG pure-NOTES procedure with endoscopic ultrasonograpy (EUS)-guided access and over-the-scope-clip (OTSC) closure was performed for 10 pigs in a survival and feasibility study. A full macroscopic necropsy with subsequent histologic evaluation was performed on postoperative day (POD) 14. The outcome parameters were uncomplicated follow-up assessment, survival, intraoperative complications, intraabdominal pathology, macroscopic full-thickness closure, and histology-proven full-thickness healing of the gastrotomy.

Results

An uncomplicated postoperative course was reported for 9 of the 10 pigs, and survival was reported for all 10 pigs. For all the pigs, EUS-guided access was performed successfully with a median duration of 25?min (range, 12–62?min) and without intraoperative complications or access-related lesions at necropsy. An OTSC closure was achieved with a median duration of 11?min (range, 3–28?min). The OTSC provided immediate closure, but according to the authors’ definition of a full-thickness healing evaluated by histologic examination, this was not achieved in any of the cases. Although all the animals survived until POD 14, intraabdominal chronic abscesses were present in 3 of the 10 pigs at necropsy.

Conclusions

The EUS-guided TG access proved to be feasible without access-related complications. Although OTSC provided an immediate closure, the histopathology raised concerns regarding the risk of perforation. Together with the high risk of intraabdominal infection, TG pure-NOTES is not yet ready for routine clinical practice.     

Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques

Background

Through-the-scope clips are commonly used for endoscopic hemostasis of gastrointestinal (GI) bleeding, but their efficacy can be suboptimal in patients with complex bleeding lesions. The over-the-scope clip (OTSC) could overcome the limitations of through-the-scope clips by allowing compression of larger amounts of tissue, allowing a more efficient hemostasis. We analyzed the use of OTSC in a consecutive case series of patients with acute GI bleeding unresponsive to conventional endoscopic treatment modalities.

Methods

In a retrospective analysis of prospectively collected data in tertiary referral centers, patients undergoing emergency endoscopy for severe acute nonvariceal GI bleeding were treated with the OTSC after failure of conventional techniques. All patients underwent repeat endoscopy 2–4 days after the procedure. Data analysis included primary hemostasis, complications, and 1-month follow-up clinical outcome.

Results

During a 10-month period, 30 patients entered the study consecutively. Bleeding lesions unresponsive to conventional endoscopic treatment (saline/adrenaline injection and through-the-scope clipping) were located in the upper and lower GI tract in 23 and 7 cases, respectively. Primary hemostasis was achieved in 29 of 30 cases (97 %). One patient with bleeding from duodenal bulb ulcer required emergent selective radiological embolization. Rebleeding occurred in two patients 12 and 24 h after the procedure; they were successfully treated with conventional saline/adrenaline endoscopic injection.

Conclusions

OTSC is an effective and safe therapeutic option for severe acute GI bleeding when conventional endoscopic treatment modalities fail.     

Over-the-scope clips in the treatment of gastrointestinal tract iatrogenic perforation: A multicenter retrospective study and a classification of gastrointestinal tract perforations

AIM: To determine the outcome of the management of iatrogenic gastrointestinal tract perforations treated by over-the-scope clip(OTSC) placement.METHODS: We retrospectively enrolled 20 patients(13 female and 7 male; mean age: 70.6 ± 9.8 years) in eight high-volume tertiary referral centers with upper or lower iatrogenic gastrointestinal tract perforation treated by OTSC placement. Gastrointestinal tract perforation could be with oval-shape or with round-shape. Ovalshape perforations were closed by OTSC only by suction and the round-shape by the "twin-grasper" plus suction. RESULTS: Main perforation diameter was 10.1 ± 4.3 mm(range 3-18 mm). The technical success rate was 100%(20/20 patients) and the clinical success rate was 90%(18/20 patients). Two patients(10%) who did not have complete sealing of the defect underwent surgery. Based upon our observations we propose two types of perforation: Round-shape "type-1 perforation" and oval-shape "type-2 perforation". Eight(40%) out of the 20 patients had a type-1 perforation and 12 patients a type-2(60%). CONCLUSION: OTSC placement should be attempted after perforation occurring during diagnostic or therapeutic endoscopy. A failed closure attempt does not impair subsequent surgical treatment.     

Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial

Background

Ulcer perforation carries up to a 30 % 1-year mortality rate. Intervention-related adverse events are among statistically significant predictors of 1-year mortality. A natural orifice transluminal endoscopic surgical (NOTES) approach may be less invasive and may decrease procedure-related adverse events by diminishing the so-called second hit, thus leading to decreased morbidity and mortality. We sought to assess the feasibility of an endoscopic transluminal omental plug technique in patients with perforated gastroduodenal ulcers under laparoscopic guidance.

Methods

Patients with suspected acute gastroduodenal ulcer perforations were offered participation in this prospective pilot study. Closure of the perforation was attempted using the NOTES omental plug technique. Demographic, clinical, endoscopic, and radiographic data were abstracted, as were data for morbidity, mortality, and pilot data regarding quality of life (QOL).

Results

From February 2010 through February 2012, a total of 17 patients presented to a tertiary care center with clinically suspected perforated ulcer. Of seven patients (mean age 79 years, range 64–89 years) who consented to the study, three underwent the study procedure. All patients had multiple comorbidities. Two patients presented with 4–6 mm perforated peptic ulcers and underwent successful laparoscopic-assisted NOTES omental and falciform ligament patch closure, respectively. Postoperative radiographic contrast studies showed no leak, and patients were discharged home on postoperative days 3 and 4. The third patient had undergone enterocutaneous fistula repair with herniorrhaphy 6 weeks before. Although a transluminal endoscopic approach was feasible, the omentum was under too much tension to be secured. This procedure was converted to an open omental patch repair. For all but one patient who provided consent, obtaining QOL data was feasible.

Conclusions

Initial results from a laparoscopic-assisted NOTES approach for closure of perforated peptic ulcers appear promising and enable swift recovery in selected patients. This is especially important in elderly and/or immunocompromised patients. Technical details and patient selection criteria continue to evolve.     

Endoscopic muscularis dissection for upper gastrointestinal subepithelial tumors originating from the muscularis propria

Background and aims

Based on our experience with endoscopic submucosal dissection (ESD) and new endoscopic techniques for endoscopic closure of iatrogenic upper gastrointestinal (upper-GI) perforations, we developed methods to remove upper-GI subepithelial tumors (SETs) originating from the muscularis propria by endoscopic?muscularis dissection (EMD). The aim of this study is to evaluate the clinical feasibility and safety of EMD.

Methods

31 patients with upper-GI SETs originating from the muscularis propria were treated by EMD. The EMD differed from ESD in (1) precutting the overlying mucosa above the lesion by using snare or longitudinal incision instead of circumferential incision, (2) dissecting the complete tumors away from submucosal and muscularis propria tissue by electrical dissection combined with blunt dissection, and (3) closing the wound with clips. Perforations occurring during dissection were closed by endoscopic methods.

Results

30 of 31 tumors were resected?completely (96.8 %). One esophageal lesion was resected partially because of severe adhesions with surrounding tissue. Mean resected tumor size was 22.1?mm?×?15.5?mm, and mean operation time was 76.8?min (range 15–330?min). Histological diagnosis was gastrointestinal stromal tumor (GIST) in 16 lesions [6 esophageal, 3 cardial, 7 gastric; 6 very low risk and 10 low risk according to the National Institutes of Health (NIH) risk classification] and leiomyoma in 15 lesions (8 esophageal, 4 cardial, 3 gastric). No patient developed delayed hemorrhage. Perforation occurred in four patients (12.9 %), all of which were managed successfully by endoscopic techniques. The mean follow-up time was 17.7?months (range 7–35?months). Follow-up found no tumor recurrence in any patient.

Conclusions

In this early experience, EMD appears to be a feasible and minimally invasive treatment for some patients with upper-GI SETs originating from the muscularis propria. Although there is a higher risk of perforation than with ESD, this will improve with extended practice, and perforations have become manageable endoscopically.     

An Endoscopic Strategy Combining Mega Stents and Over-The-Scope Clips for the Management of Post-Bariatric Surgery Leaks and Fistulas (with video)

Background and Aims

Endoscopic stenting has proved effective in the management of post-surgical leaks but is strongly hampered by the high rate of stent migration. In this study, we evaluate our experience with a new approach involving the use of novel ultra-large expandable stents tailored for bariatric surgery leaks (Mega stents), combined with the use of the innovative over-the-scope clips (OTSC).

Methods

Retrospective analysis of patients with post-bariatric surgery leaks managed at our institution by an approach combining Mega stents and over-the-scope clips.

Results

Twenty-two patients were treated for post-bariatric surgery leaks; 13 (59 %) had a sleeve gastrectomy while nine (41 %) had a RYGB. A total of 30 stents were inserted. Successful endoscopic insertion and removal were achieved in all patients. OTSC clips were applied in 12 patients (55 %); five simultaneously with stents and seven after stent removal. Primary closure (after one endoscopic procedure) was achieved in 13 patients (59 %) and in a total of 18 patients after multiple endoscopic procedures (82 %). An average of 1.4 stents and 2.8 endoscopic procedures were required per patient. Stent migration occurred in four patients (18 %), and all were retrievable endoscopically. Other complications included retrosternal pain and vomiting in 20 patients (91 %) including one necessitating early removal, bleeding in two patients (9 %), and perforation and esophageal stricture in one patient each (5 %). Two mortalities were encountered, and one of them was stent-related (bleeding).

Conclusion

Mega stents are effective in the management of post-bariatric surgery leaks. The combined use of Mega stents and OTSC clips is associated with a low incidence of migration and a low number of stents and procedures required per patient.

     

Surgical Endoscopic Vacuum Therapy for Anastomotic Leakage and Perforation of the Upper Gastrointestinal Tract

Introduction

Emergency operations for perforations and anastomotic leakage of the upper gastrointestinal tract are associated with a high overall morbidity and mortality rate. An endoscopic vacuum therapy (EVT) has been established successfully for anastomotic leakage after rectal resection but only limited data exist for EVT of the upper GI tract.

Methods

We report on a series of nine patients treated with EVT for defects of the upper intestinal tract between March 2011 and May 2012. In four patients, initial endoscopic sponge placement was performed in combination with open surgical revision. Median follow-up was 189 (range, 51?C366) days.

Results

In total, 52 vacuum sponges were placed in upper GI defects of nine patients. Indication for EVT were anastomotic leakage after esophageal resection or gastrectomy (n?=?5) and iatrogenic or spontaneous esophageal perforations (n?=?4). The mean number of sponge insertions was six (range, 1?C13) with a mean changing interval of 3.5?days (range, 2?C5). A successful vacuum therapy for upper intestinal defects was achieved in eight of nine patients (89?%).

Conclusion

EVT is a promising approach for postoperative, iatrogenic, or spontaneous lesions of the upper GI tract. If necessary the endoscopic procedure can be combined with operative revision for better control of the local septic focus.     

Is endoscopic closure with clips effective for both diagnostic and therapeutic colonoscopy-associated bowel perforation?

Background

Colonic perforation is an uncommon but serious colonoscopy-associated complication. This study assessed the effectiveness of conservative management with endoscopic clipping for colonoscopy-associated perforations.

Methods

Clinical manifestations and management outcomes were assessed for 38 patients with colonoscopy-associated colonic perforations that occurred between January 2001 and April 2008 at the Asan Medical Center, Seoul, Korea. These perforations were classified as endoscopically evident, endoscopically suspected, and radiologically proven.

Results

Of the 38 perforations, 19 were endoscopically evident, 9 were endoscopically suspected, and 10 were radiologically proven but without endoscopic evidence. Of the 19 patients with endoscopically evident perforations, 13 (68.4%) underwent endoscopic closure with clips, and all improved without surgery. All nine patients with endoscopically suspected perforations underwent endoscopic closure, and eight (88.9%) improved without surgery. Of the 10 radiologically proven perforations, 7 were detected within 1 day after colonoscopy. All the patients improved without surgery. However, two of the three patients with delayed perforations required emergency laparotomy. Consequently, of the 38 patients with perforations, 29 (76.3%) improved without surgery. Of the 28 patients with endoscopically evident or suspected perforations, conservative management was successful for 21 (95.5%) of the 22 patients with effective clipping, but for none (0%) of the 6 patients without clipping.

Conclusions

Conservative management by immediate endoscopic closure with clips can be effective for the treatment of colonic perforations detected during colonoscopy. Conservative management also may be tried cautiously for stable patients who have radiologically proven colonoscopy-associated perforations without endoscopic evidence.     

Current Evidence in Gastrointestinal Surgery: Natural Orifice Translumenal Endoscopic Surgery (NOTES)

Background

Natural orifice translumenal endoscopic surgery (NOTES) is a technique that uses transvisceral access to perform surgical procedures entirely through a natural orifice. Despite the increasing awareness of NOTES, there remain obstacles to its technical feasibility and widespread acceptance. Furthermore, with the paucity of high-level supporting evidence, NOTES currently remains an experimental technique.

Objective

This article reviews the goals, applications, technical and practical challenges, and future direction of NOTES in gastrointestinal surgery.     

Transgastric pure-NOTES peritoneoscopy and endoscopic ultrasonography for staging of gastrointestinal cancers: a survival and feasibility study

Background

Human natural orifice transluminal endoscopic surgery (NOTES) has mainly been based on simultaneous laparoscopic assistance (hybrid NOTES), forgoing the theoretical benefits of the NOTES technique. This is due to a lack of NOTES-specific instruments and endoscopes, making pure-NOTES procedures difficult and time consuming. An area where pure NOTES could be adopted at its present stage of development is minimally invasive staging of gastrointestinal (GI) cancer. The aim of this study is to evaluate the feasibility of combining transgastric (TG) pure-NOTES peritoneoscopy and intraperitoneal endoscopic ultrasonography (ip-EUS) with intraluminal EUS (il-EUS) for peritoneal evaluation.

Methods

This was a feasibility and survival study where il-EUS followed by ip-EUS and peritoneoscopy was performed in 10 pigs subjected to TG pure NOTES. A score was given with regard to achieved visualisation of predefined anatomical structures. Survival was assessed at postoperative day (POD) 14.

Results

All animals survived until POD 14. Median total procedural time was 94?min (range 74–130?min). Median time for il-EUS, ip-EUS and peritoneoscopy was 11?min (range 7–14?min), 13?min (range 8–20?min) and 10?min (range 6–23?min). Il-EUS, ip-EUS and peritoneoscopy resulted in a score of 15/15 points (range 14–15 points), 6/9 points (range 1–8 points) and 12/13 points (range 8–13 points).

Conclusions

TG pure-NOTES peritoneoscopy and ip-EUS combined with il-EUS is feasible and provides sufficient peritoneal evaluation. The technique could have potential for minimally invasive staging of GI cancers.     

Educational and training aspects of new surgical techniques: experience with the endoscopic–laparoscopic interdisciplinary training entity (ELITE) model in training for a natural orifice translumenal endoscopic surgery (NOTES) approach to appendectomy

Background

Natural orifice translumenal endoscopic surgery (NOTES) is a new surgical concept that requires training before it is introduced into clinical practice. The endoscopic–laparoscopic interdisciplinary training entity (ELITE) is a training model for NOTES interventions. The latest research has concentrated on new materials for organs with realistic optical and haptic characteristics and the possibility of high-frequency dissection. This study aimed to assess both the ELITE model in a surgical training course and the construct validity of a newly developed NOTES appendectomy scenario.

Methods

The 70 attendees of the 2010 Practical Course for Visceral Surgery (Warnemuende, Germany) took part in the study and performed a NOTES appendectomy via a transsigmoidal access. The primary end point was the total time required for the appendectomy, including retrieval of the appendix. Subjective evaluation of the model was performed using a questionnaire. Subgroups were analyzed according to laparoscopic and endoscopic experience.

Results

The participants with endoscopic or laparoscopic experience completed the task significantly faster than the inexperienced participants (p = 0.009 and 0.019, respectively). Endoscopic experience was the strongest influencing factor, whereas laparoscopic experience had limited impact on the participants with previous endoscopic experience. As shown by the findings, 87.3% of the participants stated that the ELITE model was suitable for the NOTES training scenario, and 88.7% found the newly developed model anatomically realistic.

Conclusions

This study was able to establish face and construct validity for the ELITE model with a large group of surgeons. The ELITE model seems to be well suited for the training of NOTES as a new surgical technique in an established gastrointestinal surgery skills course.