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Sponsored by: |
Maisonneuve-Rosemont Hospital |
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Information provided by: | Maisonneuve-Rosemont Hospital |
ClinicalTrials.gov Identifier: | NCT00290524 |
This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.
Condition | Intervention | Phase |
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Colorectal Neoplasms Crohn Disease |
Behavioral: Oral alimentation started 12 hours after colorectal surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery |
Estimated Enrollment: | 800 |
Study Start Date: | January 2006 |
Following intestinal surgery, the classical protocol indicates the use of a naso-gastric tube and starvation more or less prolonged of the patient dependent of surgeon's view. Decision to feed the patient is based on gas and feces reappearance after surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his hospitalization stay. Moreover, delayed feeding effect on anastomosis and wound healing is controversial and naso-gastric tube use is known to be uncomfortable and may generate secondary adverse events.
Some studies in opened surgery observed that early alimentation was beneficial against post-surgery mortality, infection risk and anastomosis dehiscence. In addition, early feeding seemed to decrease patient hospitalisation stay.
In order to conduct this study, patients having a colorectal surgery will be randomly attributed to the nil per os group, which is based on the reappearance of a functional intestinal transit, or to the experimental group, which will begin alimentation 12 hours after colorectal surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Section B: patient must meet one of the following inclusion criterion:
Exclusion Criteria:
Contact: Pierre Dubé, MD | (514) 252-3822 | pierredube@videotron.qc.ca |
Canada | |
St-Sacrement Hospital | Not yet recruiting |
Quebec, Canada | |
Principal Investigator: Louise Provencher, MD | |
Canada, Quebec | |
St-Luc Hospital | Not yet recruiting |
Montreal, Quebec, Canada | |
Principal Investigator: Carole Richard, MD | |
Ste-Marie Hospital | Not yet recruiting |
Trois-Rivieres, Quebec, Canada | |
Principal Investigator: Marie-Hélène Girouard, MD | |
Maisonneuve-Rosemont Hospital | Recruiting |
Montreal, Quebec, Canada, h1t 2m4 | |
Contact: Pierre Dubé, MD (514) 252-3822 pierredube@videotron.qc.ca | |
Principal Investigator: Pierre Dubé, MD | |
Sub-Investigator: Lucas Sidéris, MD |
Study Chair: | Pierre Dubé, MD | Maisonneuve-Rosemont Hospital |
Study ID Numbers: | QCTG-02-V5 |
Study First Received: | February 9, 2006 |
Last Updated: | April 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00290524 |
Health Authority: | Canada: Health Canada |
Oral alimentation following colorectal surgery anastomosis laparoscopy hospitalization stay |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Crohn Disease Inflammatory Bowel Diseases |
Gastrointestinal Neoplasms Gastroenteritis Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |