Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Hospitalisation stay measured in days
Pierre Dubé, MD
Canada: Health Canada