Patient with incurable disseminated left-sided colonic cancer are better palliated by colonic stenting than surgery measured by hospital free survival in "good health"(WHO-score 0 or 1) Colonic stenting is cost effective in patients with…
ID
Bron
Verkorte titel
Aandoening
incurable left-sided colonic cancer
Ondersteuning
Chaiman Board of Directors
PO Box 22660
1100 DD Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Total hospital free survival in good health (corrected for days with a WHO performance status > 1);<br>
2. Integral costs (product of volume consumed care and prices of means (personnel, overhead, material and investments).
Achtergrond van het onderzoek
Survival in patients with incurable colonic cancer is poor and is estimated at 9 months.
Morbidity associated with surgery might jeopardize successful palliation of imminent obstruction and bleeding. After hospital discharge the patient has to recover from surgery and might not reach the preoperative condition anymore due to postoperative morbidity or progressive disease. Patients who had successful colonic stenting recover very quickly from the endoscopic procedure. However, little is known how effective palliative stenting is in terms of long term relief of obstructing symptoms and early and late procedural morbidity and mortality.
The object of this study is to compare palliative treatment of (imminent) left sided obstruction in incurable colonic cancer either by surgery or colonic stenting.
Primary efficacy parameters are hospital free survival in good health (corrected for performance status) and integral costs. Based on a mean survival of 40 + 6 weeks and a difference in hospital free survival in good health of 3 weeks in favour of colonic stenting a total of 170 patients have to be included.
Doel van het onderzoek
Patient with incurable disseminated left-sided colonic cancer are better palliated by colonic stenting than surgery measured by hospital free survival in "good health"(WHO-score 0 or 1)
Colonic stenting is cost effective in patients with incurable disseminated left-sided colonic cancer.
Onderzoeksproduct en/of interventie
Surgical palliation versus "wait and see" policy and colonic stenting if obstruction is imminent.
Publiek
P.O. Box 22660
Jeanin Hooft, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
info@stent-in.nl
Wetenschappelijk
P.O. Box 22660
Jeanin Hooft, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
info@stent-in.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Left sided colonic cancer (from left flexure to > 10 cm of anus);
2. Diagnosis histological proven;
3. No signs of double tumor;
4. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Potentially curable disease;
2. ASA IV or V;
3. Ileus;
4. Karnofsky index of < 50%.
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL94 |
NTR-old | NTR125 |
Ander register | : 1206 |
ISRCTN | ISRCTN01790428 |