Early Alimentation Following Colorectal Surgery
Recruitment status was Recruiting
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.
Behavioral: Oral alimentation started 12 hours after colorectal surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery|
- Hospitalisation stay measured in days
- Gastro-intestinal signs and symptoms
- Treatment of gastro-intestinal signs and symptoms
- Post-surgery complications
|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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|