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

NCT ID: NCT01879605

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Constipation Ileus Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enema

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

Group Type EXPERIMENTAL

Docusate natrium and sorbitol

Intervention Type DRUG

Suppository

Bisacodyl, suppository 10 mg, the evening before surgery.

Group Type ACTIVE_COMPARATOR

Bisacodyl

Intervention Type DRUG

Control grup

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Docusate natrium and sorbitol

Intervention Type DRUG

Bisacodyl

Intervention Type DRUG

Other Intervention Names

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Klyx Dulcolax

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ida T Bjork, MNSc, PhD,

Role: PRINCIPAL_INVESTIGATOR

University of Oslo, Institute of Health and society

Locations

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Oslo Universitetssykehus

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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v57e4nbn

Identifier Type: -

Identifier Source: org_study_id

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