Influence of laparoscopy and/or fast-track multimodal management on gastrointestinal motility in comparison to open surgery and/or standard care
| ISRCTN | ISRCTN26698501 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26698501 |
| Secondary identifying numbers | NTR276 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Wind
Scientific
Scientific
Academic Medical Centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5663170 |
|---|---|
| J.Wind@amc.uva.nl |
Study information
| Study design | Randomised, double-blind, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TRANSIT-study |
| Study objectives | 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. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | Laparoscopic surgery and fast-track peri-operative care. 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 determined and cells will be isolated. 24 hours post-operative a labeled test-meal will be administered orally. Abdominal scans will be made 2, 24 and 48 hours after intake of the test-meal. |
| Intervention type | Other |
| Primary outcome measure | Gastrointestinal transit |
| Secondary outcome measures | 1. Clinical evaluation (passage of first stool, passage of first flatus, time till normal oral food-intake, time till discharge) 2. Intra-abdominal inflammatory status |
| Overall study start date | 01/09/2005 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Aged between 40 and 80 years 2. Colorectal cancer including colon and rectosigmoid cancers 3. Informed consent |
| Key exclusion criteria | 1. Prior midline laparotomy 2. American Society of Anaesthesiologists (ASA) grade 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Other
Internal funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
