Recruiting
Phase 3

Early Alimentation

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT00290524

Conditions

Colorectal Neoplasms

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral alimentation started 12 hours after colorectal surgery

Study Details

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.

Conditions

Colorectal Neoplasms

Crohn Disease

Study ID

NCT00290524

Start date

Jan, 2006

Status verified date

Apr, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Oral alimentation started 12 hours after colorectal surgery

Primary outcome measure

  • Hospitalisation stay measured in days [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Pierre Dubé, MD

(514) 252-3822pierredube@videotron.qc.ca

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, h1t 2m4

Contacts

Pierre Dubé, MD

(514) 252-3822pierredube@videotron.qc.ca

Principal Investigator:

Pierre Dubé, MD

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Apr 7, 2006

Last verified

Apr, 2006

Keywords

  • Oral alimentation following colorectal surgery
  • anastomosis
  • laparoscopy
  • hospitalization stay

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2006-04-07.