NCT00509327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
Last Updated

July 31, 2007

Status Verified

April 1, 2007

First QC Date

July 30, 2007

Last Update Submit

July 30, 2007

Conditions

Postoperative Ileus

Keywords

postoperative ileuscolorectal surgerybisacodyllaxatives

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of NGT reinsertion, duration of NGS reinsertion, incidence of postoperative vomiting and length of hospital stay

    10 days

Study Arms (2)

1

ACTIVE COMPARATOR

bisacodyl 10mg twice daily from one day preoperative to day three postoperative

Drug: bisacodyl

2

PLACEBO COMPARATOR

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

Drug: glucosemonohydricum

Interventions

bisacodylDRUG

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

1
glucosemonohydricumDRUG

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

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective colorectal resection
  • age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Triemli Hospital, Zurich, Switzerland

Zurich, Switzerland

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Urs Zingg, MD

    department of Surgery, University Hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Urs Metzger, Professor

    Triemli Hospital, Zurich, Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

November 1, 2004

Study Completion

February 1, 2007

Last Updated

July 31, 2007

Record last verified: 2007-04

Locations

CH(1)