Early Alimentation Following Colorectal Surgery
|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.|
|ClinicalTrials.gov Identifier: NCT00290524|
Recruitment Status : Unknown
Verified April 2006 by Maisonneuve-Rosemont Hospital.
Recruitment status was: Recruiting
First Posted : February 13, 2006
Last Update Posted : April 7, 2006
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Crohn Disease||Behavioral: Oral alimentation started 12 hours after colorectal surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery|
|Study Start Date :||January 2006|
- Hospitalisation stay measured in days
- Gastro-intestinal signs and symptoms
- Treatment of gastro-intestinal signs and symptoms
- Post-surgery complications
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): NCT00290524
|Contact: Pierre Dubé, MD||(514) email@example.com|
|Montreal, Quebec, Canada, h1t 2m4|
|Contact: Pierre Dubé, MD (514) 252-3822 firstname.lastname@example.org|
|Principal Investigator: Pierre Dubé, MD|
|Sub-Investigator: Lucas Sidéris, MD|
|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|
|St-Sacrement Hospital||Not yet recruiting|
|Principal Investigator: Louise Provencher, MD|
|Study Chair:||Pierre Dubé, MD||Maisonneuve-Rosemont Hospital|