Early Alimentation Following Colorectal Surgery

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00290524

Collaborator

(none)

800

Enrollment

Locations

200

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Crohn Disease	Behavioral: Oral alimentation started 12 hours after colorectal surgery	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Hospitalisation stay measured in days []

Secondary Outcome Measures

Gastro-intestinal signs and symptoms []
Treatment of gastro-intestinal signs and symptoms []
Post-surgery complications []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient 18 years old or more
Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E
Patient willing to participate in the study
Patient who understands and accepts to sign the informed consent form
Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B

Section B: patient must meet one of the following inclusion criterion:

segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
Closing of a terminal or loop colostomy

Exclusion Criteria:

Class ASA IV or V patient
Documented problem of gastro-intestinal motility
Pregnancy
Any acute or recent (<10 days) septic event
Chemotherapy during the 4 weeks preceding surgery
Previous irradiation surrounding the planned anastomosis location
Small intestine iatrogenic transparietal laceration done during surgery
Small intestine synchrone resection without continuity with the colon
Intra-peritoneal chemotherapy administered during or following surgery
Presence of residual peritoneal carcinosis at the end of surgery
Colic surgery associated with another major intra-abdominal surgery
Creation of a colo-anal or ileo-anal anastomosis
Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maisonneuve-Rosemont Hospital	Montreal	Quebec	Canada	h1t 2m4
2	St-Luc Hospital	Montreal	Quebec	Canada
3	Ste-Marie Hospital	Trois-Rivieres	Quebec	Canada
4	St-Sacrement Hospital	Quebec		Canada