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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms, Crohn Disease

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hospitalisation stay measured in days

Principal Investigator

Pierre Dubé, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Maisonneuve-Rosemont Hospital

Authority:

Canada: Health Canada

Study ID:

QCTG-02-V5

NCT ID:

NCT00290524

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Crohn Disease
  • Oral alimentation following colorectal surgery
  • anastomosis
  • laparoscopy
  • hospitalization stay
  • Neoplasms
  • Colorectal Neoplasms
  • Crohn Disease

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