|- candidate number||18263|
|- NTR Number||NTR4671|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-jul-2014|
|- Secondary IDs|| |
|- Public Title||Early innovative Closure of Leaking low colorEctal ANastomoses; a multicenter study.
|- Scientific Title||Early innovative Closure of Leaking low colorEctal ANastomoses; a multicenter study.
|- hypothesis||Due to an expected increase in colorectal cancer there will be a subsequent increase in Low Anterior Resections (LAR). Anastomotic leakage can occur in up to 11% of the patients after a LAR for colorectal carcinomas. Leakage interferes with stoma reversal, might compromise pouch function later on, and might result in a chronic presacral sinus precluding defect closure. A relative new technique for the treatment of anastomotic leakage is endosponge® treatment. However the traditional endosponge® treatment is associated with high material costs and a long duration of treatment. Therefore a complete new technique was developed. The early closure of the anastomotic dehiscense after endosponge® therapy might overcome these drawbacks and reduce the costs, improve the neorectum function, quality of life and improve ileostomy reversal.|
|- Healt Condition(s) or Problem(s) studied||Gastro-intestinal anastomosis, Anastomotic Leakage, Colorectal surgery|
|- Inclusion criteria||1. Anastomotic leakage after LAR (max 5 cm of the anus). |
2. Confirmed anastomotic leakage on CT-scan or endoscopy.
3. Deviated ileostoma in situ before the start of endo-sponge treatment.
4. Maximal time interval of 6 weeks between the operation and the start of the endo-sponge treatment.
5. Age > 18 years and mental competent.
6. Abscess cavity is accessible by endoscopy.
7. Patient can be followed for 2 years.
|- Exclusion criteria||1. Female patient with an ventrally located anastomotic defect |
2. Signs of sepsis for which treatment is mandatory, i.e. ICU admittance
3. Steroids of more than 20 mg/day
4. Anastomotic leakage in the medical history
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||5-jul-2013|
|- planned closingdate||5-jul-2015|
|- Target number of participants||30|
|- Interventions||As soon as the anastomotic insufficiency is diagnosed, the anastomosis is defunctioned if not done so primarily. If the CT scan shows extravasation of enteral contrast in a presacral cavity, the patient is sent to the department of Gastroenterology of one of the three intervention centers to have an endoscopy to evaluate the level of anastomosis, the size of the defect and the size of the presacral cavity. In day care one or more Endosponges® are placed in the presacral cavity in order to clean the cavity prior to closure of the anastomotic defect. The treatment is continued until the cavity is clean. Within 7 – 14 days after initiation of Endosponge® treatment, the anastomotic gap is attempted to close with interrupted sutures under general anesthetics. If not succesfull, Endosponge® treatment is continued until closure of the cavity.|
|- Primary outcome||Primary outcome parameters are the number of ostomies successfully closed within 3 months. Success is be defined as normal defecation after stoma closure without signs of sepsis 3 months after closure. |
|- Secondary outcome||Secondary parameters are number of anastomotic defects closed within 2-3 weeks, time to closure of the defunctioning ostomy, quality of life, costs, functional outcome after closure, duration of endosponge treatment an the need for surgical re-intervention for each closure technique.
|- Timepoints|| 3, 6, 9 and 12 months |
|- Trial web site||www.clean-study.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. W.A. Bemelman|
|- CONTACT for SCIENTIFIC QUERIES||MD. G.D. Musters|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||2-jul-2014 - 3-aug-2014|