Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

NCT ID: NCT00427492

Last Updated: 2009-02-11

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Magnesia

Medical laxative

Group Type ACTIVE_COMPARATOR

Magnesia

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Magnesia

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with planned elective colonic resection

Exclusion Criteria

* Previous extended abdominal surgery
* Pregnancy
* Opioid or alcohol abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Copenhagen University Hospital - Hvidovre

Principal Investigators

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Jens Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Hvidovre

Locations

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Copenhagen University hospital Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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02 290964

Identifier Type: -

Identifier Source: org_study_id

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