|- candidate number||3431|
|- NTR Number||NTR1340|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jun-2008|
|- Secondary IDs||Senter grant NR TSGE 3141 MEC University Medical Center Groningen|
|- Public Title||Protection of colorectal anastomoses with a biodegradable device: The C-SEAL feasibility study.|
|- Scientific Title||Protection of colorectal anastomoses with a biodegradable device: The C-SEAL feasibility study.|
|- hypothesis||Protection with a biodegradable sheath will reduce the number of anastomotic leakage.|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer, Anastomotic leakage|
|- Inclusion criteria||1. Age 18-80. |
2. Patient requires anastomosis, maximally 15 cm from the anus.
3. Patient will recieve a colorectal anatomosis by means of stapling.
4. Patient is willing and able to comply with the specified follow-ip evaluation.
5. Patient or legally representative has given written consent.
|- Exclusion criteria||See inclusion, if not, than exclusion|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2005|
|- planned closingdate||31-dec-2006|
|- Target number of participants||15|
|- Interventions||Prior to performing a colorectal anastomosis, a biodegradable sheath was glued to the anvil of the circular stapler. in doing so, firing the circular stapler resulted in a fixation of the protective drain to the tissue just proximally of the simultaneously made anastomosis.|
|- Primary outcome||Position of sheath after one week, demonstrated by water-soluble contrast enema imaging.|
|- Secondary outcome||- Userfriendliness |
- Compatibility with stapler device
- Patient confort
- Duration of degradation
- Anastomotic leakage
|- Timepoints||- One week postoperative |
- 6 weeks postoperative
- 3 months postoperative
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| J.L.P. Kolkert|
|- CONTACT for SCIENTIFIC QUERIES|| J.L.P. Kolkert|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Polyganics BV|
(Source(s) of Monetary or Material Support)
|- Brief summary||Colorectal surgery is associated with a high morbidity and mortality due to anastomotic leakage. We have assessed the feasibility of a new biodegradable intraluminal sheath, designed to avoid anastomotic leakage. It was tested in fifteen patients. The sheath was well compatible to the standard stapler device used in colorectal surgery and easy to employ. Patients experienced only minimal discomfort due to the sheath. No radiological or clinical leakage was observed.
|- Main changes (audit trail)|
|- RECORD||6-jun-2008 - 25-jul-2008|