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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879605
• Other study ID #: v57e4nbn
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2013
• Last updated: June 17, 2013
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Ileus
• Surgery

Intervention

Drug:
• Docusate natrium and sorbitol

• Bisacodyl

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The study's outcome measures were recorded every evening between 17.00 and 21.00 hours		Nausea	No
Other	Pain		The study's outcome measures were recorded every evening between 17.00 and 21.00 hours	No
Primary	Defecation within 72 hours postoperatively		The study's outcome measures were recorded every evening between 17.00 and 21.00 hours	No
Secondary	Postoperative constipation		The study's outcome measures were recorded every evening between 17.00 and 21.00 hours	No