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ISRCTN
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ISRCTN66787074
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ClinicalTrials.gov identifier
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Public title
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CLosure of acute colonIc Perforations: endoscoPic OTSC closurE versus suRgical closure
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Scientific title
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CLosure of acute colonIc Perforations: endoscoPic OTSC closurE versus suRgical closure: a randomised controlled trial
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Acronym
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CLIPPER II
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Serial number at source
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January 2011/02/34159
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Study hypothesis
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Endoscopic closure of acute colonic perforations following a colonoscopy with the Over-the-Scope-Clip (OTSC) is as successful and safe as surgical closure, but with less procedure related morbidity, better cosmesis and procedure related costs.
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Lay summary
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Lay summary under review 1
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Ethics approval
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Medical Ethics Committee of the Academic Medical Centre Amsterdam, 03 March 2011 ref: 10/246
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Study design
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Randomised controlled multi-centre trial
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Countries of recruitment
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Belgium, Denmark, France, Germany, Italy, Netherlands, Switzerland
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Disease/condition/study domain
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Acute colonic perforation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2011
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Anticipated end date
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01/07/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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54
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Interventions
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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 surgical closure. The Over-The-Scope-Clip system (OTSC) is an endoscopic device that consists of a large nitinol clip pre-loaded on a transparent plastic cap. The cap is mounted on the tip of an endoscope and the clip can be released by rotating a wheel, which is attached to the shaft of the endoscope. To approximate both sides of the perforation, a twin grasper is deployed through the working channel of the endoscope.
The twin grasper has one fixed middle branch and two independently movable lateral branches, which enable grasping of both perforation edges separately. The tissue is approximated and gently pulled into the cap while applying continuous suction. The OTSC is released by pulling on a wire that is led through the working channel of the endoscope.
Surgical closure of the perforation will consist of a preferably laparoscopic procedure according to the standard operating procedure of the respective study center within 6 hours after the perforation occurred. The perforated colon will be explored and the perforation will be repaired surgically with primary closure (suturing), resection with primary anastomosis or resection with diversion (stoma) at the surgeons’ preference.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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, 14
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Sources of funding
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Academic Medical Center Amsterdam (Netherlands)
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Trial website
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Publications
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Contact name
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Prof
Paul
Fockens
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Address
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Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Email
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p.fockens@amc.uva.nl
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Sponsor
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Academic Medical Centre Amsterdam (Netherlands)
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Address
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Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.nl/
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Date applied
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17/06/2011
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Last edited
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30/01/2012
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Date ISRCTN assigned
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30/01/2012
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