Early Alimentation Following Colorectal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasms, Crohn Disease

Intervention / Treatment
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* Behavioral: Oral alimentation started 12 hours after colorectal surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Oral alimentation started 12 hours after colorectal surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation stay measured in days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-intestinal signs and symptoms |  |  | 
| Treatment of gastro-intestinal signs and symptoms |  |  | 
| Post-surgery complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral alimentation following colorectal surgery, anastomosis, laparoscopy, hospitalization stay