Condition category
Surgery
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
14/12/2007
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 C van der Leeuw

ORCID ID

Contact details

Atrium Medisch Centrum Heerlen
Chirurgie
Heerlen
6401 CX
Netherlands
+31 (0)64 847 7103
C.vanderLeeuw@student.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL14234.096.06

Study information

Scientific title

Acronym

BP LSCS

Study hypothesis

The objective of this study is to ascertain the best method of bowel preparation, prior to elective left-sided colonic surgery in terms of patient comfort and surgical efficacy. Sodium phosphate enemas (Colex) and bisacodyl (tablet and suppository) are to be compared. The occurrence of infections (wound, peritonitis) and anastomotic leaks will be monitored.

Null hypotheses are:
1. Patients in both groups experience pain and discomfort equally
2. The surgeon finds no difference in the condition of the left hemicolon intraoperatively
3. No difference in incidence of infection is found
4. No difference in incidence of anastomotic leaks is found

Ethics approval

Approval received from the local ethics committee (Medisch Ethische Toetsingscommissie Atrium MC - Maaslandziekenhuis) on the 30th October 2006.

Study design

Randomised, active controlled, parallel group, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bowel preparation, sodium phosphate enema, solonic surgery, bisacodyl

Intervention

Interventions in the bisacodyl group:
1. Evening before surgery (8 p.m.) - bisacodyl tablet 5 mg, four tablets, oral administration
2. Morning of surgery (6 a.m.) - bisacodyl suppository 10 mg, one suppository, rectal administration

Intervention in the Colex group:
1. Evening before surgery (8 p.m.) - Colex 133 ml, enema, rectal administration
2. Morning of surgery (6 a.m.) - Colex 133 ml, enema, rectal administration

Intervention type

Drug

Phase

Not Specified

Drug names

Bisacodyl, sodium phosphate (Colex)

Primary outcome measures

Questionnaires will be used to assess the opinions of patients and surgeons. The parameters are recorded in a five point scale.

Secondary outcome measures

The occurrence of infection (wound or peritonitis) and anastomotic leaks is determined by standard postoperative care and is established when the clinical diagnosis is made.

Overall trial start date

06/11/2006

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

The study population will consist of adult patients undergoing elective left-sided colonic surgery. Left-sided colonic surgery includes the following procedures:
1. Left hemicolectomy
2. Sigmoid resection
3. Low anterior resection
4. Hartmann procedure
5. Reconstruction of colostomy
6. Abdominoperineal resection by Miles

Procedures on the transverse colon will also be included as this can result intraoperatively in a left hemicolectomy. Reasons for surgery vary, examples are malignancy, diverticulitis, Crohns disease and ulcerative colitis.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Exclusion criteria are:
1. Use of Klean-Prep
2. Contra-indications for use of bisacodyl and Colex
3. Emergency procedures

Recruitment start date

06/11/2006

Recruitment end date

01/06/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Atrium Medisch Centrum Heerlen
Heerlen
6401 CX
Netherlands

Sponsor information

Organisation

Atrium Medisch Centrum (The Netherlands)

Sponsor details

P.O. Box 4446
Heerlen
6401 CX
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.atriummc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Atrium Medisch Centrum (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