Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00427492
First received: January 26, 2007
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Colonic Cancer
Drug: Magnesia
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Time to defecation after colonic resection [ Time Frame: 2-8 days ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesia
Medical laxative
Drug: Magnesia
Tablet magnesia 500mg. 2 tablet 2 times a day for a week
Drug: Placebo
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients with planned elective colonic resection

Exclusion Criteria:

  • Previous extended abdominal surgery
  • Pregnancy
  • Opioid or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427492

Locations
Denmark
Copenhagen University hospital Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Jens Andersen, MD Copenhagen University Hospital, Hvidovre
  More Information

No publications provided

Responsible Party: Jens Andersen. Consultant Surgeon, Copenhagen University Hospital - Hvidovre
ClinicalTrials.gov Identifier: NCT00427492     History of Changes
Other Study ID Numbers: 02 290964
Study First Received: January 26, 2007
Last Updated: February 10, 2009
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Laxatives
Cathartics
Magnesium Oxide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014