Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer Surgery (NUTRICOLON)

Hospital General Universitario Reina Sofía de Murcia

Status: Unknown

Conditions: Nutrition Support; Nutrition Related Neoplasm/Cancer; Site Infection; Surgery--Complications; Colorectal Cancer

Treatments: Dietary Supplement: Nutrition supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04059731

NUTRICOLON

Details and patient eligibility

About

The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST).

Full description

The study is a randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate the non-inferiority in efficacy and therapeutic safety of the postoperative diet with oligomeric-hyperprotéic-normocaloric supplement (group 1) versus a supplement with imunonutrients (group 2), in a multimodal rehabilitation regimen (ERAS) of colorectal surgery for colon cancer and that arrive at surgery in a normal nutritional state or without any intervention on their nutritional status, according to the scale Malnutrition Screening Tool (MST). The study will be carried out in the General Surgery and Digestive Diseases Services of the following hospitals:

• Reina Sofía University General Hospital (HGURS) of Murcia.
• Sagunto Hospital, Valencia.
• University Hospital of Fuenlabrada, Madrid.

Primary objective: to demonstrate the non-inferiority in the therapeutic efficacy of a postoperative diet with an oligomeric-hyperprotéic-normocaloric supplement versus a supplement with imunonutrients, in patients under the multimodal rehabilitation regimen (fast-track) of colorectal surgery of colon cancer and who arrive at the Surgery in normal nutritional status or without any intervention on their nutritional status, according to the Malnutrition Screening Tool (MST) scale. The proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery will be considered the main parameter of effectiveness.

Secondary Objectives: to demonstrate the non-inferiority in therapeutic safety of a postoperative diet with oligomeric-hyperprotéic-normocaloric supplement versus a supplement with imunonutrients, in a multimodal rehabilitation regimen (ERAS) of colon cancer colorectal surgery, through:

1. The evaluation in each treatment group of the oral tolerance to the supplements, considering as a total adherence if the indicated daily volume (400ml) is consumed, partial adhesion if it is half of the indicated volume (200ml) and non-adherence if it is less than 200 ml / day.
2. Comparison of the percentage of patients in each treatment group of postoperative complications according to the Clavien-Dindo classification, up to 30 days from the date of surgery.
3. Comparison of the percentage of patients in each treatment group of surgical site infection according to the classification of Centers for Disease Control and Prevention -CDC- , up to 30 days from the date of surgery.
4. The comparison in each treatment group of the percentage of patients who have required hospital readmission or have died attributed to the surgical act, up to 30 days from the date of surgery.
5. The comparison in each treatment group of the average postoperative hospital stay.
6. The evaluation in each group of treatment of analytical parameters: before nutritional supplementation prescribed by its responsible surgeon or the unit of nutrition, the day before surgery and the fifth postoperative day or the day of discharge: hemoglobin, leukocytes, lymphocytes, procalcitonin, C-reactive protein, total proteins, albumin, prealbumin, transferrin and creatinine.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being over 18 years.
• Clinical diagnosis (pre-surgical) of colorectal carcinoma stage I-III, classification TNM, 6th edition.
• Normal nutritional status or without any intervention on their nutritional status, with a score lower than 2 according to the Malnutrition Screening Tool (MST) scale.
• Accepts participating in the Multimodal Rehabilitation Clinical Pathway in Patients submitted to a Bowel, Colorectal Anastomosis of HGURS.
• Accept signing informed consent.

Exclusion criteria

• Age under 18.
• Clinical diagnosis (pre-surgical) of colorectal carcinoma stage IV.
• ASA Staging (American Society of Anesthesiologists) IV
• Chronic renal failure in dialysis.
• Pregnant.
• Difficulty or inability to understand the purpose of the study and controls.
• Refuses to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

Surmimed®OPD Drink

Experimental group

Description:

Normocaloric oligomeric-hyperprotein supplement

Treatment:

Dietary Supplement: Nutrition supplement

Atempero® or Impact®

Active Comparator group

Description:

Inmunonutrition

Treatment:

Dietary Supplement: Nutrition supplement