NCT01879605
Completed
Phase 4
Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial
Oslo University Hospital1 site in 1 country45 target enrollmentDecember 2007
Overview
- Phase
- Phase 4
- Intervention
- Docusate natrium and sorbitol
- Conditions
- Constipation
- Sponsor
- Oslo University Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Defecation within 72 hours postoperatively
- Status
- Completed
- Last Updated
- 12 years ago
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.
Investigators
Eligibility Criteria
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
Docusate natrium and sorbitol, 240 ml enema, the evening before surgery
Intervention: Docusate natrium and sorbitol
Suppository
Bisacodyl, suppository 10 mg, the evening before surgery.
Intervention: Bisacodyl
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)
Study Sites (1)
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