Condition category
Infections and Infestations
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
26/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes