Clinical trial NCT04059731: Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Related Neoplasm/Cancer
Colorectal Cancer
Surgery--Complications
Site Infection
Nutrition Support
Lead sponsor: Hospital General Universitario Reina Sofía de Murcia
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, multicentric, double-blind, controlled with active comparator, parallel groups trial, to demonstrate non-inferiority in efficacy and therapeutic safety
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Oral Tolerance
timeFrame: 5 days
measure: Clavien-Dindo Complications
timeFrame: 30 days
measure: Site Infection
timeFrame: 30 days
measure: Readmission
timeFrame: 30 days
measure: Death
timeFrame: 30 days
measure: Hospital Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
Study officials:
affiliation: Hospital General Universitario Reina Sofía
name: Jorge Alejandro Benavides Buleje, PhD
role: PRINCIPAL_INVESTIGATOR
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