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The C-seal study.


- candidate number7949
- NTR NumberNTR2302
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2010
- Secondary IDs2009.078 METc UMCG
- Public TitleThe C-seal study.
- Scientific TitleColorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler: A phase II study.
- ACRONYM
- hypothesisIn 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) studiedRectal cancer, Anastomotic leakage, Surgical treatment, Low anterior resection
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-feb-2010
- planned closingdate1-aug-2010
- Target number of participants35
- InterventionsPlacement 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 outcomeTo estimate the occurrence of anastomotic leakage when the C-seal is used.
- Secondary outcome1. 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.
- Timepoints1. During hospitalisation, 6 weeks and 3 months after surgery: Assessment of end points;
2. One week after surgery: Rectal contrast enema.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.N. Morks
- CONTACT for SCIENTIFIC QUERIESM.D. Phd. K. Havenga
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Polyganics B.V.
- PublicationsProtection 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 summaryColorectal 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)
- RECORD19-apr-2010 - 9-mei-2010


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