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Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery

Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00509327
Enrollment
200
Registered
2007-07-31
Start date
2004-11-30
Completion date
2007-02-28
Last updated
2007-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

postoperative ileus, colorectal surgery, bisacodyl, laxatives

Brief summary

Postoperative bowel dysmotility is a frequent condition after colorectal surgery. The influence of colon stimulating laxatives have not been studied. This prospective, randomized, double blind, placebo controlled study assesses the influence of bisacodyl on postoperative bowel motility in patients undergoing elective colorectal surgery. The hypothesis of this trial was that bisacodyl has a beneficial effect on the duration of postoperative ileus.

Detailed description

All adult (\>18 years) patients admitted for elective colorectal resection were evaluated for eligibility. 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.

Interventions

DRUGbisacodyl

10mg capsule twice daily from one day preoperatively to day three postoperatively

DRUGglucosemonohydricum

10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* elective colorectal resection * age \>18 years

Exclusion criteria

* preoperatively planned stoma formation * emergency surgery * pregnancy * known hypersensitivity for bisacodyl

Design outcomes

Primary

MeasureTime frame
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 tolerated10 days

Secondary

MeasureTime frame
Incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay10 days

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026