Effect of Postoperative Laxative on Bowel Function After Colonic Surgery
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| ClinicalTrials.gov Identifier: NCT00427492 |
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Recruitment Status
:
Completed
First Posted
: January 29, 2007
Last Update Posted
: February 11, 2009
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Sponsor:
Hvidovre University Hospital
Information provided by:
Hvidovre University Hospital
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colonic Cancer | Drug: Magnesia Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 56 participants |
| 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 |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bowel Movement
Drug Information available for:
Magnesium oxide
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Magnesia
Medical laxative
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Drug: Magnesia
Tablet magnesia 500mg. 2 tablet 2 times a day for a week
Drug: Placebo
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo |
Primary Outcome Measures
:
- Time to defecation after colonic resection [ Time Frame: 2-8 days ]
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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
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 |
| Responsible Party: | Jens Andersen. Consultant Surgeon, Copenhagen University Hospital - Hvidovre |
| ClinicalTrials.gov Identifier: | NCT00427492 History of Changes |
| Other Study ID Numbers: |
02 290964 |
| First Posted: | January 29, 2007 Key Record Dates |
| Last Update Posted: | February 11, 2009 |
| Last Verified: | February 2009 |
Additional relevant MeSH terms:
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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 |