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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00509327
First received: July 30, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postoperative Ileus
Drug: bisacodyl
Drug: glucosemonohydricum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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 [ Time Frame: 10 days ]

Secondary Outcome Measures:
  • Incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay [ Time Frame: 10 days ]

Enrollment: 200
Study Start Date: November 2004
Study Completion Date: February 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective colorectal resection
  • age >18 years

Exclusion Criteria:

  • preoperatively planned stoma formation
  • emergency surgery
  • pregnancy
  • known hypersensitivity for bisacodyl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509327

Locations
Switzerland
Department of Surgery, Triemli Hospital, Zurich, Switzerland
Zurich, Switzerland
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00509327     History of Changes
Other Study ID Numbers: 2004DR4256
Study First Received: July 30, 2007
Last Updated: July 30, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
postoperative ileus
colorectal surgery
bisacodyl
laxatives

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014