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

Colorectal Cancer Clinical Trial

— NUTRICOLON  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04059731
• Other study ID #: NUTRICOLON
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: August 2019
• Source: Hospital General Universitario Reina Sofía de Murcia
• Contact: Emilio Peña Ros, PhD
• Phone: 686797476
• Email: emilio.doctor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 20, 2020
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms
• Nutrition Related Neoplasm/Cancer
• Nutrition Support
• Site Infection
• Surgery--Complications

Intervention

Dietary Supplement:
• Nutrition supplement
Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days

Locations

Country	Name	City	State
Spain	Hospital General Universitario Reina Sofía	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Reina Sofía de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Anderson DJ, Podgorny K, Berríos-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. — View Citation

Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 14. — View Citation

García de Lorenzo A, Álvarez Hernández 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. Review. — View Citation

García-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. Review. Spanish. — View Citation

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. Review. — View Citation

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. — View Citation

Skipworth RJ, Fearon KC. The scientific rationale for optimizing nutritional support in cancer. Eur J Gastroenterol Hepatol. 2007 May;19(5):371-7. Review. — View Citation

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. — View Citation

Wanden-Berghe C, Sanz-Valero J, Arroyo-Sebastián 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. Review. Spanish. — View Citation

Weimann A, Braga M, Carli F, Higashiguchi T, Hübner 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Stay	The comparison in each treatment group of the average postoperative hospital stay.	30 days