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

Primary Purpose

Constipation, Ileus, Surgery

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Docusate natrium and sorbitol
Bisacodyl
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Spinal surgery, Bowel preparation, Ileus, Constipation, Well-being

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo Universitetssykehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Enema

Suppository

Control grup

Arm Description

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

Bisacodyl, suppository 10 mg, the evening before surgery.

No intervention

Outcomes

Primary Outcome Measures

Defecation within 72 hours postoperatively

Secondary Outcome Measures

Postoperative constipation

Full Information

First Posted
June 13, 2013
Last Updated
June 17, 2013
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01879605
Brief Title
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery
Official Title
Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Ileus, Surgery
Keywords
Spinal surgery, Bowel preparation, Ileus, Constipation, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enema
Arm Type
Experimental
Arm Description
Docusate natrium and sorbitol, 240 ml enema, the evening before surgery
Arm Title
Suppository
Arm Type
Active Comparator
Arm Description
Bisacodyl, suppository 10 mg, the evening before surgery.
Arm Title
Control grup
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Docusate natrium and sorbitol
Other Intervention Name(s)
Klyx
Intervention Type
Drug
Intervention Name(s)
Bisacodyl
Other Intervention Name(s)
Dulcolax
Primary Outcome Measure Information:
Title
Defecation within 72 hours postoperatively
Time Frame
The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Secondary Outcome Measure Information:
Title
Postoperative constipation
Time Frame
The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Other Pre-specified Outcome Measures:
Title
The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Time Frame
Nausea
Title
Pain
Time Frame
The study's outcome measures were recorded every evening between 17.00 and 21.00 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida T Bjork, MNSc, PhD,
Organizational Affiliation
University of Oslo, Institute of Health and society
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

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

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