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Influence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.


- candidate number1402
- NTR NumberNTR276
- ISRCTNISRCTN26698501
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleInfluence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.
- Scientific TitleInfluence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.
- ACRONYMTRANSIT-study
- hypothesisThat minimal invasive laparoscopic surgery and/or multimodal patient care (fast track) can prevent post operative ileus and/or improve post-surgical gastrointestinal motility compared to open surgery and/or conventional patient care.
- Healt Condition(s) or Problem(s) studiedColorectal cancer
- Inclusion criteria1. Age between 40 and 80 years;
2. Colorectal cancer including colon and rectosigmoid cancers;
3. Informed consent.
- Exclusion criteria1. Prior midline laparotomy;
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Prior upper and/or lower midline laparotomy;
5. Emergency colectomy;
6. Contraindications for epidural (coagulation disorders);
7. Planned stoma.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-jul-2007
- Target number of participants80
- InterventionsLaparoscopic surgery and fast track perioperative care.
- Primary outcomeGastrointestinal transit.
- Secondary outcomeClinical evaluation (passage of first stool, passage of first flatus, time till normal oral food-intake, time till discharge) Intra ľabdominal inflammatory status.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESM.D. J. Wind
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.A. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Internal funding
- PublicationsN/A
- Brief summaryPostoperative ileus (POI) is defined as delayed recovery of gastrointestinal motor function (motility) and is still considered an unavoidable consequence of abdominal surgery.

Aim:
To evaluate to what extend minimal invasive laparoscopic surgery and/or multimodal patient care (fast track) can prevent POI and/or improve post-surgical gastrointestinal motility if compared to open surgery and/or conventional patient care.

Patients and methods:
The current study protocol is an addendum on the LAFA protocol.
At the start and at the end of the surgical procedure peritoneal lavage fluid and blood samples are collected. Cytokine levels in these samples will be determent and cells will be isolated.
24 hours postoperative a labeled test-meal will be administered orally. Abdominal scans will be made 2, 24 and 48 hours after intake of the test-meal.
- Main changes (audit trail)
- RECORD6-sep-2005 - 3-dec-2009


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