Effect of Postoperative Laxative on Bowel Function After Colonic Surgery
This study has been completed.
Sponsor:
Hvidovre University Hospital
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00427492
First received: January 26, 2007
Last updated: February 10, 2009
Last verified: February 2009
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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:
MedlinePlus related topics:
Bowel Movement
Drug Information available for:
Magnesium oxide
U.S. FDA Resources
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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00427492
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
| 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:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Magnesium Oxide Laxatives Cathartics Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 26, 2016