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

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: Colorectal Cancer; Surgery--Complications; Site Infection; Nutrition Support; Nutrition Related Neoplasm/Cancer
• Intervention / Treatment: Dietary supplement: Nutrition supplement

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

• Study Contact: Name: Emilio Peña Ros, PhD; Phone Number: 686797476; Email: emilio.doctor@gmail.com

Study Locations

• Spain
  • Murcia, Spain, 30003
    • Recruiting
    • Hospital General Universitario Reina Sofía
    • Contact: Emilio Peña Ros, PhD; Phone Number: +34686797476; Email: emilio.doctor@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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	The comparison in each treatment group of the average postoperative hospital stay.	30 days

Collaborators and Investigators

• 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

General Publications

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Garcia-Luna PP, Parejo Campos J, Pereira Cunill JL. [Causes and impact of hyponutrition and cachexia in the oncologic patient]. Nutr Hosp. 2006 May;21 Suppl 3:10-6. Spanish.
• Ferguson M, Capra S, Bauer J, Banks M. Development of a valid and reliable malnutrition screening tool for adult acute hospital patients. Nutrition. 1999 Jun;15(6):458-64. doi: 10.1016/s0899-9007(99)00084-2.
• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
• Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27. doi: 10.1086/676022.
• Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
• Thornblade LW, Varghese TK Jr, Shi X, Johnson EK, Bastawrous A, Billingham RP, Thirlby R, Fichera A, Flum DR. Preoperative Immunonutrition and Elective Colorectal Resection Outcomes. Dis Colon Rectum. 2017 Jan;60(1):68-75. doi: 10.1097/DCR.0000000000000740.
• Wanden-Berghe C, Sanz-Valero J, Arroyo-Sebastian A, Cheikh-Moussa K, Moya-Forcen P. [Effects of a nutritional intervention in a fast-track program for a colorectal cancer surgery: systematic review]. Nutr Hosp. 2016 Jul 19;33(4):402. doi: 10.20960/nh.402. Spanish.
• Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. doi: 10.1017/S0007114507832909.
• Kreymann KG. Early nutrition support in critical care: a European perspective. Curr Opin Clin Nutr Metab Care. 2008 Mar;11(2):156-9. doi: 10.1097/MCO.0b013e3282f44c41.
• Skipworth RJ, Fearon KC. The scientific rationale for optimizing nutritional support in cancer. Eur J Gastroenterol Hepatol. 2007 May;19(5):371-7. doi: 10.1097/MEG.0b013e3280bdbf87.
• Finco C, Magnanini P, Sarzo G, Vecchiato M, Luongo B, Savastano S, Bortoliero M, Barison P, Merigliano S. Prospective randomized study on perioperative enteral immunonutrition in laparoscopic colorectal surgery. Surg Endosc. 2007 Jul;21(7):1175-9. doi: 10.1007/s00464-007-9238-4. Epub 2007 Mar 14.
• Garcia de Lorenzo A, Alvarez Hernandez J, Planas M, Burgos R, Araujo K; multidisciplinary consensus work-team on the approach to hospital malnutrition in Spain. Multidisciplinary consensus on the approach to hospital malnutrition in Spain. Nutr Hosp. 2011 Jul-Aug;26(4):701-10. doi: 10.1590/S0212-16112011000400006.

Study record dates

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: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms
• 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