No registrations found.
ID
Source
Brief title
Health condition
Colorectal cancer
Sponsors and support
Intervention
Outcome measures
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 –abdominal inflammatory status.
Background summary
Postoperative 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.
Study objective
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.
Study design
N/A
Intervention
Laparoscopic surgery and fast track perioperative care.
P.O. Box 22660
J. Wind
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663170
J.Wind@amc.uva.nl
P.O. Box 22660
J. Wind
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663170
J.Wind@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL238 |
NTR-old | NTR276 |
Other | : N/A |
ISRCTN | ISRCTN26698501 |