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

June 17, 2013 updated by: Oslo University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo Universitetssykehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enema
Docusate natrium and sorbitol, 240 ml enema, the evening before surgery
Drug: Docusate natrium and sorbitol
Other Names:
  • Klyx
Active Comparator: Suppository
Bisacodyl, suppository 10 mg, the evening before surgery.
Drug: Bisacodyl
Other Names:
  • Dulcolax
No Intervention: Control grup
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Defecation within 72 hours postoperatively
Time Frame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Ida T Bjork, MNSc, PhD,, University of Oslo, Institute of Health and Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v57e4nbn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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