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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Drug: bisacodyl; Drug: glucosemonohydricum

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland
    • Department of Surgery, Triemli Hospital, Zurich, Switzerland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective colorectal resection
• age >18 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; bisacodyl 10mg twice daily from one day preoperative to day three postoperative	Drug: bisacodyl; 10mg capsule twice daily from one day preoperatively to day three postoperatively
Placebo Comparator: 2; 10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative	Drug: glucosemonohydricum; 10mg of glucosemonohydricum twice daily from one day preoperative to day three postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 tolerated	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay	10 days

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Urs Zingg, MD, department of Surgery, University Hospital Basel, Switzerland; Study Director: Urs Metzger, Professor, Triemli Hospital, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: July 30, 2007
• First Submitted That Met QC Criteria: July 30, 2007
• First Posted (Estimate): July 31, 2007

Study Record Updates

• Last Update Posted (Estimate): July 31, 2007
• Last Update Submitted That Met QC Criteria: July 30, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: colorectal surgery; laxatives; postoperative ileus; bisacodyl
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: 2004DR4256