Protection with a biodegradable sheath will reduce the number of anastomotic leakage.
ID
Bron
Verkorte titel
Aandoening
COLORECTAL CANCER
ANASTOMOTIC LAEKAGE
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Position of sheath after one week, demonstrated by water-soluble contrast enema imaging.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Protection with a biodegradable sheath will reduce the number of anastomotic leakage.
Onderzoeksopzet
- One week postoperative
- 6 weeks postoperative
- 3 months postoperative
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
See inclusion, if not, than exclusion
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1293 |
| NTR-old | NTR1340 |
| Ander register | MEC University Medical Center Groningen : Senter grant NR TSGE 3141 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |