Bowel Preparation for elective Left-Sided Colonic Surgery
| ISRCTN | ISRCTN91751187 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91751187 |
| Protocol serial number | NL14234.096.06 |
| Sponsor | Atrium Medisch Centrum (The Netherlands) |
| Funder | Atrium Medisch Centrum (The Netherlands) |
- 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
Scientific
Atrium Medisch Centrum Heerlen
Chirurgie
Heerlen
6401 CX
Netherlands
| Phone | +31 (0)64 847 7103 |
|---|---|
| C.vanderLeeuw@student.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, single blinded trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bisacodyl, sodium phosphate (Colex) |
| Primary outcome measure(s) |
Questionnaires will be used to assess the opinions of patients and surgeons. The parameters are recorded in a five point scale. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
6401 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
