Early Alimentation Following Colorectal Surgery

April 6, 2006 updated by: Maisonneuve-Rosemont Hospital

Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Quebec, Canada
        • Not yet recruiting
        • St-Sacrement Hospital
        • Principal Investigator:
          • Louise Provencher, MD
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital
        • Sub-Investigator:
          • Lucas Sidéris, MD
        • Contact:
        • Principal Investigator:
          • Pierre Dubé, MD
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • St-Luc Hospital
        • Principal Investigator:
          • Carole Richard, MD
      • Trois-Rivieres, Quebec, Canada
        • Not yet recruiting
        • Ste-Marie Hospital
        • Principal Investigator:
          • Marie-Hélène Girouard, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hospitalisation stay measured in days

Secondary Outcome Measures

Outcome Measure
Gastro-intestinal signs and symptoms
Treatment of gastro-intestinal signs and symptoms
Post-surgery complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

  • Study Chair: Pierre Dubé, MD, Maisonneuve-Rosemont Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2006

Last Update Submitted That Met QC Criteria

April 6, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QCTG-02-V5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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