Darmvoorbereiding bij linkszijdige colonchirurgie
- Conditions
- Bowel preparation for elective left-sided colonic surgery will be investigated. Medical conditions requiring this type of treatment vary, examples are inflammatory and malignant diseases.
- Registration Number
- EUCTR2006-004746-16-NL
- Lead Sponsor
- Atrium Medisch Centrum Parkstad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Prinicipal inclusion criteria are:
Adults (18 years or older) undergoing elective left-sided colonic surgery (left hemicolectomy, sigmoid resection, low anterior resection, abdominoperineal resection according to Miles, reconstruction of colostomy). In addition procedures on the transverse colon (as this procedure can result in a left hemicolectomy) and rectal surgery will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria include objection to participation by the treating physician, preparation for rectal surgery with Klean-Prep, contra-indications to the administration of bisacodyl or Colex and emergency procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to determine the most effective method of bowel preparation for elective left-sided colonic surgery. Bisacodyl (tablet and suppository) and Colex (enema) are to be compared in terms of patient comfort and surgical efficacy.;Secondary Objective: Secondary objectives of the trial are to ascertain the occurence of infection (wound, peritonitis) and anastomotic leaks. ;Primary end point(s): Primary end points are:<br>- patient comfort<br>- surgical efficacy<br>
- Secondary Outcome Measures
Name Time Method