Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery
NCT ID: NCT00509327
Last Updated: 2007-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2004-11-30
2007-02-28
Brief Summary
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Detailed Description
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Patients were randomized using a computer programme and received either 10mg of bisacodyl in non-transparent capsules or identical placebo capsules, containing glucosemonohydricum. The capsules were administered twice daily, starting one day before surgery and ending on postoperative day three.Patients and all involved medical personnel were blinded.
Bowel preparation was not routinely used in open surgery, whereas in patients undergoing laparoscopic resection two litres of sodium-sulfate / macrogol solution (Cololyt®, Spirig Pharma AG, Switzerland) was administered. Standard colorectal surgery was performed in all patients. In open surgery a midline incision was used for laparotomy. In laparoscopic resections a four-port technique with removal of the specimen through a small transverse incision in the lower abdomen was used. All patients received perioperative single shot antibiotics, cefuroxime 1.5 g and metronidazole 1g. Nasogastric tube (NGT) was scheduled to be removed at the end of surgery. Postoperative treatment was not changed during the study. All patients received postoperatively a basic analgesia of 500 to 1000 mg oral paracetamol every 6 h; additionally, metamizol was administrated intravenously or orally as needed.
The primary endpoint was the time to recovery of gastrointestinal function, defined as the mean time to the occurrence of the following three events (GI-3): first flatus passed, first defecation and first solid food tolerated. We did not include the presence of bowel movement, as they may be present before recovery of the colon due to small bowel activity24. Secondary endpoints were the incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay. Additionally, consumption of analgesics and pain, cramping and nausea scores (assessed with a visual analogue scale \[VAS\]) during the first 8 postoperative days were monitored. Other variables recorded were patients' demographics, use of epidural anaesthesia, type and duration of surgery and morbidity.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
bisacodyl 10mg twice daily from one day preoperative to day three postoperative
bisacodyl
10mg capsule twice daily from one day preoperatively to day three postoperatively
2
10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
glucosemonohydricum
10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
Interventions
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bisacodyl
10mg capsule twice daily from one day preoperatively to day three postoperatively
glucosemonohydricum
10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative
Eligibility Criteria
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Inclusion Criteria
* age \>18 years
Exclusion Criteria
* emergency surgery
* pregnancy
* known hypersensitivity for bisacodyl
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Principal Investigators
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Urs Zingg, MD
Role: PRINCIPAL_INVESTIGATOR
department of Surgery, University Hospital Basel, Switzerland
Urs Metzger, Professor
Role: STUDY_DIRECTOR
Triemli Hospital, Zurich, Switzerland
Locations
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Department of Surgery, Triemli Hospital, Zurich, Switzerland
Zurich, , Switzerland
Countries
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Other Identifiers
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2004DR4256
Identifier Type: -
Identifier Source: org_study_id