CLosure of acute colonIc Perforations: endoscoPic OTSC closurE versus suRgical closure

Completed

• Conditions: Acute colonic perforation; Surgery

• Registration Number: ISRCTN66787074
• Lead Sponsor: Academic Medical Centre Amsterdam (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Documented colonic perforation: clear view of the peritoneum or other visceral organs documented by endoscopic picture or video. In case of doubt a plain abdominal X-ray or computerised tomography (CT) can be taken to detect intraperitoneal air
2. Etiology
3. Endoscope perforation during colonoscopy
4. Perforation during polypectomy, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
5. Perforation size 1-3 cm in diameter as can be estimated with the jaws of an open biopsying forceps (8 mm)
6. Colon prepared for colonoscopy with good or excellent result and no solid stool remaining
7. Detection of perforation within 3 hours of the procedure

Exclusion Criteria

1. Tumour perforation
2. Suspicion of severe contamination of the abdominal cavity with digestive organ content
3. Sepsis
4. American Society of Anesthesiologists (ASA) class IV or V

Study & Design

• Study Type: Interventional
• Study Design: Not specified