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Laparoscopic-assisted versus open ileocolic resection for Crohn's disease.


- candidate number5158
- NTR NumberNTR1585
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2009
- Secondary IDs99/108 MEC
- Public TitleLaparoscopic-assisted versus open ileocolic resection for Crohn's disease.
- Scientific TitleLaparoscopic-assisted versus open ileocolic resection for Crohn's disease.
- ACRONYMlaptop studie
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedCrohn's disease, Ileocecal resection
- Inclusion criteria1. Patients with Crohn's disease scheduled for an elective ileocolic resection;
2. age above 16 years.
- Exclusion criteria1. Fixed palpable inflammatory mass prior to surgery;
2. prior median laparotomy;
3. earlier bowel resection;
4. pregnancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate15-sep-2008
- Target number of participants60
- InterventionsA laparoscopic-assisted or an open ileocolic resection.
- Primary outcomeShort term:
1. postoperative quality of life.

Long term primary outcomes:
1. intestinal disease recurrence;
2. no. of reoperations for incisional hernia;
3. no. of reoperations for adhesive small bowel obstruction.
- Secondary outcomeShort term:
1. operating time;
2. blood loss;
3. conversion rate;
4. early morbidity;
5. morphine requirement;
6. pain VAS scores;
7. mortality;
8. hospital stay;
9. costs.


Long term outcomes:
1. QOL;
2. body image and cosmesis.
- TimepointsInclusion: 01-01-2000 - 01-10-2003.
Short term results published: february 2006.
Long term results assesed: 15-09-2008.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.A. Bemelman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.A. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publicationslaparoscopic-assisted versus open ileocolic resection for Crohn's disease - a randomized trial (ann surg feb;243(2):143-9; discussion 150-3).
- Brief summaryAn 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.
- Main changes (audit trail)
- RECORD14-jan-2009 - 23-jan-2009


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