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
Secondary identifying numbers N/A
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

Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 9111
Email W.A.Bemelman@amc.uva.nl

Study information

Study designRandomised, double-blind, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymBactTrans
Study objectivesWe 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) studiedBacterial translocation and intestinal permeability
InterventionDevascularisation beginning left or right in case of laparoscopic colectomy. In case of open colectomy mobilisation from lateral to medial.
Intervention typeOther
Primary outcome measure1. Intestinal permeability, measured before, during and directely after surgery
2. Amount of bacterial translocation, measured before, during and directely after surgery
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/03/2006
Completion date01/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2006
Date of final enrolment01/07/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan