|- candidate number||1402|
|- NTR Number||NTR276|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Influence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.|
|- Scientific Title||Influence of laparoscopy and/or fast track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care.|
|- hypothesis||That 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) studied||Colorectal cancer|
|- Inclusion criteria||1. Age between 40 and 80 years;|
2. Colorectal cancer including colon and rectosigmoid cancers;
3. Informed consent.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-jul-2007|
|- Target number of participants||80|
|- Interventions||Laparoscopic surgery and fast track perioperative care.|
|- Primary outcome||Gastrointestinal transit.|
|- Secondary outcome||Clinical evaluation (passage of first stool, passage of first flatus, time till normal oral food-intake, time till discharge)
Intra ľabdominal inflammatory status.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||M.D. J. Wind |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. W.A. Bemelman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Postoperative ileus (POI) is defined as delayed recovery of gastrointestinal motor function (motility) and is still considered an unavoidable consequence of abdominal surgery. |
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)|
|- RECORD||6-sep-2005 - 3-dec-2009|