Bowel Preparation for elective Left-Sided Colonic Surgery

ISRCTN	ISRCTN91751187
DOI	https://doi.org/10.1186/ISRCTN91751187
Secondary identifying numbers	NL14234.096.06

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 14/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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 C van der Leeuw
Scientific

Atrium Medisch Centrum Heerlen
Chirurgie
Heerlen
6401 CX
Netherlands

Phone	+31 (0)64 847 7103
Email	C.vanderLeeuw@student.unimaas.nl

Study information

Study design	Randomised, active controlled, parallel group, single blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	BP LSCS
Study objectives	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(s)	Approval received from the local ethics committee (Medisch Ethische Toetsingscommissie Atrium MC - Maaslandziekenhuis) on the 30th October 2006.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bisacodyl, sodium phosphate (Colex)
Primary outcome measure	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 study start date	06/11/2006
Completion date	01/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	40
Key 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.
Key exclusion criteria	Exclusion criteria are: 1. Use of Klean-Prep 2. Contra-indications for use of bisacodyl and Colex 3. Emergency procedures
Date of first enrolment	06/11/2006
Date of final enrolment	01/06/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Atrium Medisch Centrum Heerlen

Heerlen
6401 CX
Netherlands

Sponsor information

Atrium Medisch Centrum (The Netherlands)
Hospital/treatment centre

P.O. Box 4446
Heerlen
6401 CX
Netherlands

Website	http://www.atriummc.nl/
"ROR"	https://ror.org/0367sye10

Funders

Funder type

Hospital/treatment centre

Atrium Medisch Centrum (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan