No registrations found.
ID
Source
Brief title
Health condition
COLORECTAL CANCER
ANASTOMOTIC LAEKAGE
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
Protection with a biodegradable sheath will reduce the number of anastomotic leakage.
Study design
- One week postoperative
- 6 weeks postoperative
- 3 months postoperative
Intervention
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.
Department of Surgery
PO Box 30 001
J.L.P. Kolkert
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
j.l.p. kolkert@chir.umcg.nl
Department of Surgery
PO Box 30 001
J.L.P. Kolkert
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
j.l.p. kolkert@chir.umcg.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1293 |
| NTR-old | NTR1340 |
| Other | MEC University Medical Center Groningen : Senter grant NR TSGE 3141 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |