Early Alimentation Following Colorectal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Maisonneuve-Rosemont Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00290524
First received: February 9, 2006
Last updated: April 6, 2006
Last verified: April 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

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

Estimated Enrollment: 800
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290524

Contacts
Contact: Pierre Dubé, MD (514) 252-3822 pierredube@videotron.qc.ca

Locations
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, h1t 2m4
Contact: Pierre Dubé, MD    (514) 252-3822    pierredube@videotron.qc.ca   
Principal Investigator: Pierre Dubé, MD         
Sub-Investigator: Lucas Sidéris, MD         
St-Luc Hospital Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Carole Richard, MD         
Ste-Marie Hospital Not yet recruiting
Trois-Rivieres, Quebec, Canada
Principal Investigator: Marie-Hélène Girouard, MD         
Canada
St-Sacrement Hospital Not yet recruiting
Quebec, Canada
Principal Investigator: Louise Provencher, MD         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
Study Chair: Pierre Dubé, MD Maisonneuve-Rosemont Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00290524     History of Changes
Other Study ID Numbers: QCTG-02-V5
Study First Received: February 9, 2006
Last Updated: April 6, 2006
Health Authority: Canada: Health Canada

Keywords provided by Maisonneuve-Rosemont Hospital:
Oral alimentation following colorectal surgery
anastomosis
laparoscopy
hospitalization stay

Additional relevant MeSH terms:
Colorectal Neoplasms
Crohn Disease
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Inflammatory Bowel Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014