Contact information
Type
Scientific
Primary contact
Dr W.A. Bemelman
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 9111
W.A.Bemelman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BactTrans
Study hypothesis
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
Ethics approval received from the Medical Ethics Committee AMC, Amsterdam on the 26th April 2006 (ref: MEC 06/045).
Study design
Randomised, double-blind, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Intestinal permeability, measured before, during and directely after surgery
2. Amount of bacterial translocation, measured before, during and directely after surgery
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary