Bacterial Translocation and intestinal permeability in patients undergoing open or laparoscopic total colectomy: open, right side or left side first laparoscopically
| ISRCTN | ISRCTN82467578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82467578 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 26/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 W.A. Bemelman
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| W.A.Bemelman@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BactTrans |
| Study objectives | We hypothesise that bacterial translocation is the least in open colectomy followed by laparoscopic colectomy starting the devascularisation on the left side followed by laparoscopic colectomy starting the devascularisation on the right side. The longer period of devascularisation results in an increased permeability and higher risk of bacterial translocation. |
| Ethics approval(s) | Ethics approval received from the Medical Ethics Committee AMC, Amsterdam on the 26th April 2006 (ref: MEC 06/045). |
| Health condition(s) or problem(s) studied | Bacterial translocation and intestinal permeability |
| Intervention | Devascularisation beginning left or right in case of laparoscopic colectomy. In case of open colectomy mobilisation from lateral to medial. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Intestinal permeability, measured before, during and directely after surgery |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Aged greater than 18 years 2. Patients planned for laparoscopic total colectomy for inflammatory bowel diseases or familial adenomatous polyposis or patients undergoing subtotal colectomy 3. Informed consent |
| Key exclusion criteria | 1. Antibiotics within a week prior to surgery (perioperative antibiotics are allowed) 2. Use of probiotic products four weeks before or during the study |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
