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Clinical Trials/NCT01879605
NCT01879605CompletedPhase 4

Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial

Oslo University Hospital1 site in 1 country45 target enrollmentStarted: December 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
Defecation within 72 hours postoperatively

Study Overview

Brief Summary

This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

Detailed Description

This was a randomised clinical trial with one control group and two treatment groups.

Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing spinal fusion surgery
  • Age 15 years or older
  • The patients had to understand oral and written Norwegian.
  • Postoperative pain management via epidural catheter should have been planned.

Exclusion Criteria

  • Constipation
  • Regularly use of enema

Arms & Interventions

Enema

Experimental

Docusate natrium and sorbitol, 240 ml enema, the evening before surgery

Intervention: Docusate natrium and sorbitol (Drug)

Suppository

Active Comparator

Bisacodyl, suppository 10 mg, the evening before surgery.

Intervention: Bisacodyl (Drug)

Outcomes

Primary Outcomes

Defecation within 72 hours postoperatively

Time Frame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Secondary Outcomes

  • Postoperative constipation(The study's outcome measures were recorded every evening between 17.00 and 21.00 hours)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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