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Early Alimentation Following Colorectal Surgery

Primary Purpose

Colorectal Neoplasms, Crohn Disease

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Oral alimentation started 12 hours after colorectal surgery
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Oral alimentation following colorectal surgery, anastomosis, laparoscopy, hospitalization stay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Maisonneuve-Rosemont HospitalRecruiting
  • St-Luc Hospital
  • Ste-Marie Hospital
  • St-Sacrement Hospital

Outcomes

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

Full Information

First Posted
February 9, 2006
Last Updated
April 6, 2006
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00290524
Brief Title
Early Alimentation Following Colorectal Surgery
Official Title
Prospective, Multicentric, Randomized Phase III Study Comparing Early Oral Alimentation to Nil Per Os Diet After Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Crohn Disease
Keywords
Oral alimentation following colorectal surgery, anastomosis, laparoscopy, hospitalization stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Oral alimentation started 12 hours after colorectal surgery
Primary Outcome Measure Information:
Title
Hospitalisation stay measured in days
Secondary Outcome Measure Information:
Title
Gastro-intestinal signs and symptoms
Title
Treatment of gastro-intestinal signs and symptoms
Title
Post-surgery complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Dubé, MD
Phone
(514) 252-3822
Email
pierredube@videotron.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
h1t 2m4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
Phone
(514) 252-3822
Email
pierredube@videotron.qc.ca
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
First Name & Middle Initial & Last Name & Degree
Lucas Sidéris, MD
Facility Name
St-Luc Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Richard, MD
Facility Name
Ste-Marie Hospital
City
Trois-Rivieres
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Girouard, MD
Facility Name
St-Sacrement Hospital
City
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Provencher, MD

12. IPD Sharing Statement

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Early Alimentation Following Colorectal Surgery

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