Acute colonic perforation Surgery Acute colonic perforation
Conditions
Interventions
Surgical closure (gold standard) vs endoscopic closure with Over-the-Scope-Clip
Treatment of the iatrogenic colonic perforations will be either endoscopic with the Over-The-Scope-Clip or with surgica
Sponsors
Academic Medical Centre Amsterdam (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Closure-related morbidity, defined as clinical leakage or leakage seen on CT with enteral contrast requiring surgical intervention or radiological drainage within 30 days after the closure procedure 2. Clinical leakage, defined as abdomninal wall rigidity and tenderness associated with relative temperature rise, leucocytosis and relative C-reactive protein (CRP) rise | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse event that leads to death, additional intervention or prolonged hospital stay within 30 days after the procedure 1. Hospital stay (days) following closure of colonic perforation (solid diet should be started within 12 hours following the procedure) the patient will be discharged from the hospital in case of adequate pain control with oral medication and patients? acceptance to be discharged. These ?discharge criteria? should be checked daily 2. Procedure and hospital stay related costs (direct and indirect costs) 3. Number of days needing analgetics (preferably, the patient should indicate whether analgetics are needed so that the (minimal) use and type of analgetics can be scored) 4. Day of return to normal daily activities 5. Closure time defined as time starting from introduction of the endoscope with the OTSC or the first surgical incision, until adequate closure 6. Quality of life as measured by SF-36 questionnaire at day 1, 3, 8 and 14 | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Switzerland
Outcome results
None listed