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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509327
• Other study ID #: 2004DR4256
• Status: Completed
• Phase: Phase 4
• First received: July 30, 2007
• Last updated: July 30, 2007
• Start date: November 2004
• Est. completion date: February 2007

Study information

• Verified date: April 2007
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• elective colorectal resection

• age >18 years

Exclusion Criteria:

• preoperatively planned stoma formation

• emergency surgery

• pregnancy

• known hypersensitivity for bisacodyl

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Switzerland	Department of Surgery, Triemli Hospital, Zurich, Switzerland	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		10 days
Secondary	Incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay		10 days