In Crohn's disease patients requiring an ileocolic resection, a laparoscopic-assisted approach will reduce morbidity, costs and will improve postoperative quality of life when compared to the conventional open approach.
ID
Bron
Verkorte titel
Aandoening
Crohn's disease - ziekte van Crohn
steroid refractory - steroid refractair
ileocolic resection - ileocecaal resectie
laparoscopic-assisted - laparoscopisch-geassisteerd
open approach - open benadering
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Short term:<br>
1. postoperative quality of life.
<br><br>
Long term primary outcomes:<br>
1. intestinal disease recurrence;<br>
2. no. of reoperations for incisional hernia;<br>
3. no. of reoperations for adhesive small
bowel obstruction.
Achtergrond van het onderzoek
An ileocolic resection can be performed both by an open approach as well as by a laparoscopic procedure. Aim of this trial is to compare short- and long term results of those different approaches by means of a multicentered, randomized trial. Short term outcome parameters are quality of life, costs and perioperative details such as operating time; blood loss; conversion rate; early morbidity; morphine requirement; pain VAS scores; mortality; hospital stay. Long term outcome parameters are intestinal disease recurrence; no. of reoperations for incisional hernia; no. of reoperations for adhesive small bowel obstruction; QOL and body image and cosmesis.
Doel van het onderzoek
In Crohn's disease patients requiring an ileocolic resection, a laparoscopic-assisted approach will reduce morbidity, costs and will improve postoperative quality of life when compared to the conventional open approach.
Onderzoeksopzet
Inclusion: 01-01-2000 - 01-10-2003.
Short term results published: february 2006.
Long term results assesed: 15-09-2008.
Onderzoeksproduct en/of interventie
A laparoscopic-assisted or an open ileocolic resection.
Publiek
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with Crohn's disease scheduled for an elective ileocolic resection;
2. age above 16 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Fixed palpable inflammatory mass prior to surgery;
2. prior median laparotomy;
3. earlier bowel resection;
4. pregnancy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1516 |
| NTR-old | NTR1585 |
| Ander register | MEC : 99/108 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |