|- candidate number||7949|
|- NTR Number||NTR2302|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2010|
|- Secondary IDs||2009.078 METc UMCG|
|- Public Title||The C-seal study.|
|- Scientific Title||Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: A phase II study.|
|- hypothesis||In this phase II study the main objective is the assessment of the occurrence of anastomotic leakage with the use of the C-seal. The assessment will take place one week after the operation, and 6 and 12 weeks after the procedure.
|- Healt Condition(s) or Problem(s) studied||Rectal cancer, Anastomotic leakage, Surgical treatment, Low anterior resection|
|- Inclusion criteria||1. Age > 18 years;|
2. The patient requires an anastomosis, maximally 15 cm proximal from the anus;
3. The patient will receive a colorectal anastomosis by means of stapling;
4. The patient is willing and able to comply with the specified follow-up evaluation;
5. The patient must provide written informed consent prior to the procedure.
|- Exclusion criteria||1. Patient treatment is acute (not elective);|
2. Patient is associated with infections at the time of intervention (peritonitis);
3. Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study;
4. Patients with ASA classification > 3.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||8-feb-2010|
|- planned closingdate||1-aug-2010|
|- Target number of participants||35|
|- Interventions||Placement of the C-seal in a stapled colorectal anastomosis. C-seal is a biofragmentable drain, which is stapled to the anastomosis with a circular stapler. It covers the luminal side of the colorectal anastomosis. The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage. |
|- Primary outcome||To estimate the occurrence of anastomotic leakage when the C-seal is used.|
|- Secondary outcome||1. The assessment of technical feasibility defined as technical success, determined by a gastrografin enema X-ray of the rectum one week after the operation;|
2. The successful clearance of the C-seal at 6 weeks without the occurrence of a serious adverse event;
3. Estimation of patient friendliness of the drain, at one week and 6 weeks;
4. Technical success: The Technical success is defined as the successful application of the C-seal;
5. Acute procedural success: Acute procedural success is defined as the successful application of the C-seal without the occurrence of a Serious Adverse Effects (SAE) caused by the drain/protector during or directly after the procedure;
6. Procedural success: The successful placement of the C-seal and the successful clearance of the C-seal with absence of any serious adverse events up to 30 days.
|- Timepoints||1. During hospitalisation, 6 weeks and 3 months after surgery: Assessment of end points;|
2. One week after surgery: Rectal contrast enema.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.N. Morks|
|- CONTACT for SCIENTIFIC QUERIES||M.D. Phd. K. Havenga|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG), Polyganics B.V.|
|- Publications||Protection of stapled colorectal anastomoses with a biodegradable device: the C-seal feasibility study
Kolkert JL, Havenga K, ten Cate Hoedemaker HO, Zuidema J, Ploeg RJ. Accepted for publication in American Journal of Surgery.|
|- Brief summary||Colorectal anastomotic leakage (AL) is a serious complication in colorectal surgery leading to high morbidity and mortality rates. A new device is developed in our institute aimed at protecting the colorectal anastomosis and lowering the incidence of AL. This so called C-seal is a biofragmentable drain, which is stapled to the anastomosis with a circular stapler. It covers the luminal side of the colorectal anastomosis. The C-seal does not prevent the formation of dehiscences. However, it prevents extravasation of faeces into the peritoneal cavity. This means that a gap at the anastomotic site does not lead to leakage. |
A pilot study, testing the C-seal in 15 patients, showed that the C-seal can be succesfully applied in colorectal surgery. The C-seal was well compatible with the circular stapler and easy to employ. No anastomotic leakages were observed in these 15 patients.
|- Main changes (audit trail)|
|- RECORD||19-apr-2010 - 9-mei-2010|