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Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Primary Purpose

Colonic Cancer

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Magnesia

Placebo

About this trial

This is an interventional supportive care trial for Colonic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

Patients with planned elective colonic resection

Exclusion Criteria:

Previous extended abdominal surgery
Pregnancy
Opioid or alcohol abuse

Sites / Locations

Copenhagen University hospital Hvidovre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesia

Placebo

Arm Description

Medical laxative

Placebo

Outcomes

Primary Outcome Measures

Time to defecation after colonic resection

Secondary Outcome Measures

Full Information

NCT ID

NCT00427492

First Posted

January 26, 2007

Last Updated

February 10, 2009

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00427492

Brief Title

Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Official Title

Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnesia

Arm Type

Active Comparator

Arm Description

Medical laxative

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Magnesia

Intervention Description

Tablet magnesia 500mg. 2 tablet 2 times a day for a week

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time to defecation after colonic resection

Time Frame

2-8 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: Patients with planned elective colonic resection Exclusion Criteria: Previous extended abdominal surgery Pregnancy Opioid or alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Andersen, MD

Organizational Affiliation

Copenhagen University Hospital, Hvidovre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University hospital Hvidovre

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

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Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

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