Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery

Phase 4

Completed

• Conditions: Constipation; Ileus; Surgery
• Interventions: Drug: Bisacodyl; Drug: Docusate natrium and sorbitol

• Registration Number: NCT01879605
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study Start: 2007-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-17
• Last Update Submitted: 2013-06-17
• Study First Posted: 2013-06-18
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Suppository	Bisacodyl	Bisacodyl, suppository 10 mg, the evening before surgery.
Enema	Docusate natrium and sorbitol	Docusate natrium and sorbitol, 240 ml enema, the evening before surgery

Primary Outcome Measures

Name	Time	Method
Defecation within 72 hours postoperatively	The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative constipation	The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Trial Locations

Locations (1)

Oslo Universitetssykehus; 🇳🇴 Oslo, Norway