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Effect of Postoperative Laxative on Bowel Function After Colonic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427492
First Posted: January 29, 2007
Last Update Posted: February 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with planned elective colonic resection

Exclusion Criteria:

  • Previous extended abdominal surgery
  • Pregnancy
  • Opioid or alcohol abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jens Andersen. Consultant Surgeon, Copenhagen University Hospital - Hvidovre
ClinicalTrials.gov Identifier: NCT00427492     History of Changes
Other Study ID Numbers: 02 290964
First Submitted: January 26, 2007
First Posted: January 29, 2007
Last Update Posted: February 11, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Laxatives
Cathartics
Magnesium Oxide
Gastrointestinal Agents
Antacids
Molecular Mechanisms of Pharmacological Action