Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Color… (NCT04059731) | Clinical Trial Compass
UnknownNot Applicable
Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer Surgery
Spain108 participantsStarted 2019-06-20
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative complications
Timeframe: 30 days
Trial details
NCT IDNCT04059731
SponsorHospital General Universitario Reina Sofía de Murcia