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NCT00427492 Clinical Trial

Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Colonic Cancer Clinical Trial

Official title:
Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00427492
Other study ID # 02 290964
Secondary ID
Status Completed
Phase Phase 4
First received January 26, 2007
Last updated February 10, 2009
Start date January 2007
Est. completion date January 2009

Study information
Verified date February 2009
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with planned elective colonic resection

Exclusion Criteria:

- Previous extended abdominal surgery

- Pregnancy

- Opioid or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Magnesia
Tablet magnesia 500mg. 2 tablet 2 times a day for a week
• Placebo

Locations
Country Name City State
Denmark Copenhagen University hospital Hvidovre Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to defecation after colonic resection 2-8 days Yes
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