Status:
UNKNOWN
Early Alimentation Following Colorectal Surgery
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Conditions:
Colorectal Neoplasms
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00290524
Start Date
January 1 2006
Last Update
April 7 2006
Active Locations (4)
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1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, h1t 2m4
2
St-Luc Hospital
Montreal, Quebec, Canada
3
St-Sacrement Hospital
Québec, Quebec, Canada
4
Ste-Marie Hospital
Trois-Rivières, Quebec, Canada