Study About Effect of Preoperative Bowel Preparation Vers... | NCT01879605

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

NCT01879605

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jun 18, 2013Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Constipation
Ileus
Surgery

Interventions

Docusate natrium and sorbitol
Bisacodyl

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 13, 2013

First Submission Date that Met QC Criteria

Jun 17, 2013

First Posted Date

Jun 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2013

Last Update Posted Date

Jun 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enema	Experimental	Docusate natrium and sorbitol, 240 ml enema, the evening before surgery	Drug: Docusate natrium and sorbitol
Suppository	Active Comparator	Bisacodyl, suppository 10 mg, the evening before surgery.	Drug: Bisacodyl
Control grup	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docusate natrium and sorbitol	Drug		Enema	Klyx
Bisacodyl

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ida T Bjork, MNSc, PhD,	University of Oslo, Institute of Health and society	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo Universitetssykehus		Oslo	Oslo	0424	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation
D045823	Ileus

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007415	Intestinal Obstruction

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013012	Sorbitol
D001726	Bisacodyl

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided