|- candidate number||2435|
|- NTR Number||NTR881|
|- Date ISRCTN created||26-feb-2007|
|- date ISRCTN requested||21-feb-2007|
|- Date Registered NTR||28-jan-2007|
|- Secondary IDs||NL14234.096.06 |
|- Public Title||Bowel preparation for elective left-sided colonic surgery.|
|- Scientific Title||Bowel preparation for elective left-sided colonic surgery.|
|- ACRONYM||BP LSCS|
|- 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.
|- Healt Condition(s) or Problem(s) studied||Bowel preparation, Colonic surgery, Sodium phosphate enema, Bisacodyl|
|- Inclusion criteria||The study population will consist of adult patients undergoing elective left-sided colonic surgery. Left-sided colonic surgery includes the following procedures: left hemicolectomy, sigmoid resection, low anterior resection, Hartmann procedure, reconstruction of colostomy and 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, Crohn disease and ulcerative colitis.|
|- Exclusion criteria||Exclusion criteria are:|
1. Use of Klean-Prep;
2. Contra-indications for use of bisacodyl and Colex;
3. Emergency procedures.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-nov-2006|
|- planned closingdate||1-jun-2007|
|- Target number of participants||40|
|- Interventions||Interventions in the bisacodyl group:|
Evening before surgery, 8 PM - bisacodyl tablet 5 mg, 4 tablets, oral administration;
Morning of surgery, 6 AM - bisacodyl suppository 10 mg, 1 suppository, rectal administration.
Intervention in the Colex group:
Evening before surgery, 8 PM - Colex 133 ml, enema, rectal administration;
Morning of surgery, 6 AM - Colex 133 ml, enema, rectal administration.
|- Primary outcome||Questionnaires will be used to assess the opinions of patients and surgeons. The parameters are recorded in a five point scale.|
|- Secondary outcome||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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| C. Leeuw, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr M. Sosef|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad, Maaslandziekenhuis|
(Source(s) of Monetary or Material Support)
|Atrium Medisch Centrum Parkstad |
|- Brief summary||The objective of the randomized clinical trial "Bowel preparation for elective left-sided colonic surgery" is to compare sodium phosphate enemas (Colex) and bisacodyl (tablet and suppository) in terms of surgical efficacy and patient comfort.
The trial is single blind (surgeon is masked). Concealment of allocation is upheld. The primary outcomes (as described above) will be assessed through a 5-point questionnaire completed by surgeon and patient. Secondary to this the incidence of complications such as wound infection and anastomotic leaks will be monitored. |
|- Main changes (audit trail)|
|- RECORD||28-jan-2007 - 1-dec-2009|