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

August 14, 2019 updated by: Hospital General Universitario Reina Sofía de Murcia

Randomized, Multicentric, Double-blind, Controlled Trial of Parallel Groups to Evaluate the Non-inferiority of a Postoperative Diet With an Oligomeric-hyperprotein-normocaloric Versus Imunonutrients After Surgery for Colorectal Cancer.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30003
        • Recruiting
        • Hospital General Universitario Reina Sofía
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surmimed®OPD Drink
Normocaloric oligomeric-hyperprotein supplement
Dietary supplement: Nutrition supplement
Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days
Active Comparator: Atempero® or Impact®
Inmunonutrition
Dietary supplement: Nutrition supplement
Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Tolerance
Time Frame: 5 days
The evaluation in each treatment group of the oral tolerance to the supplements, as a total adherence if the indicated daily volume (400 ml) is consumed, the partiality of half of the indicated volume (200 ml) and is not met in the minor . 200 ml / day.
5 days
Clavien-Dindo Complications
Time Frame: 30 days
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.
30 days
Site Infection
Time Frame: 30 days
Comparison of the percentage of patients in each treatment group of the surgical site infection according to the classification of the Centers for Disease Control and Prevention -CDC- , up to 30 days from the date of surgery
30 days
Readmission
Time Frame: 30 days
The comparison in each treatment group of the percentage of patients who have required hospital readmission attributed to the surgical act, up to 30 days from the date of surgery.
30 days
Death
Time Frame: 30 days
The comparison in each treatment group of the percentage of patients who have died attributed to the surgical act, up to 30 days from the date of surgery.
30 days
Hospital Stay
Time Frame: 30 days
The comparison in each treatment group of the average postoperative hospital stay.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Reina Sofía de Murcia

Investigators

  • Principal Investigator: Jorge Alejandro Benavides Buleje, PhD, Hospital General Universitario Reina Sofía

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Anticipated)

August 10, 2019

Study Completion (Anticipated)

June 20, 2020

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUTRICOLON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe