NCT04059731

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 9, 2019

Last Update Submit

August 14, 2019

Conditions

Nutrition Related Neoplasm/CancerColorectal CancerSurgery--ComplicationsSite InfectionNutrition Support

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    proportion of subjects in each research group without postoperative complications after 1 month (30 days) of surgery

    30 days

Secondary Outcomes (6)

  • Oral Tolerance

    5 days

  • Clavien-Dindo Complications

    30 days

  • Site Infection

    30 days

  • Readmission

    30 days

  • Death

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Surmimed®OPD Drink

EXPERIMENTAL

Normocaloric oligomeric-hyperprotein supplement

Dietary Supplement: Nutrition supplement

Atempero® or Impact®

ACTIVE COMPARATOR

Inmunonutrition

Dietary Supplement: Nutrition supplement

Interventions

Nutrition supplementDIETARY_SUPPLEMENT

Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days

Atempero® or Impact®Surmimed®OPD Drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

RECRUITING

Related Publications (13)

  • 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.

    PMID: 10378201BACKGROUND

  • 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.

    PMID: 28385477BACKGROUND

  • 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.

    PMID: 15273542BACKGROUND

  • 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.

    PMID: 24799638BACKGROUND

  • 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.

    PMID: 27227930BACKGROUND

  • 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.

    PMID: 27926559BACKGROUND

  • 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.

    PMID: 27571677BACKGROUND

  • Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. doi: 10.1017/S0007114507832909.

    PMID: 17922951BACKGROUND

  • 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.

    PMID: 18301092BACKGROUND

  • 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.

    PMID: 17413286BACKGROUND

  • 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.

    PMID: 17356942BACKGROUND

  • 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.

    PMID: 16768026BACKGROUND

  • 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.

    PMID: 22470013BACKGROUND

MeSH Terms

Conditions

NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jorge Alejandro Benavides Buleje, PhD

    Hospital General Universitario Reina Sofía

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Peña Ros, PhD

CONTACT

686797476emilio.doctor@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The masking procedure of the reference treatment and the study treatment will be carried out in the pharmacy service, since the packaging of the two treatments is different, brick and bottle. Pharmacy will keep the list of randomization, so at all times the pharmacy service will know which group each patient belongs to. Both treatments will be re-packaged in 250 ml topaz plastic bottles (Code 225433) with the same label. The re-packaging will be carried out daily in aseptic conditions and by pharmacy personnel, it will be done per patient and in no time neither the patient nor the researcher will know the group to which the patient belongs. In the program that the pharmacy service uses for the realization of the master formulas, the formula NUTRICOLON will be created with its corresponding procedure and label, always keeping the confidentiality of the product used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate non-inferiority in efficacy and therapeutic safety
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 16, 2019

Study Start

June 20, 2019

Primary Completion

August 10, 2019

Study Completion

June 20, 2020

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)