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Not yet recruiting NCT07599501

Nutritional Supplementation to Improve Colorectal Cancer Surgery

No phase Interventional Colorectal Cancer Colorectal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diet Optimization (DO), Oral Nutritional Supplement (ONS).
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colorectal Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial

Overview

This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.

Detailed description

The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.

Interventions

  • Other Diet Optimization (DO)
    Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
  • Dietary supplement Oral Nutritional Supplement (ONS)
    ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium).

Primary outcome measures

  • Postoperative complications [Time frame: 30 days from surgery]
Secondary outcome measures (9)
  • Postoperative septic complications [Time frame: 30 days from surgery]
  • Comprehensive Complication Index (CCI) [Time frame: 30 days from surgery]
  • Length of hospital stay [Time frame: 30 days from surgery]
  • Hospital readmission [Time frame: 30 days from surgery]
  • Sarcopenia [Time frame: Six months after surgery]
  • Normal weight [Time frame: 60 days after surgery]
  • Mini Nutritional Assessment (MNA) score [Time frame: 60 days after surgery]
  • EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score [Time frame: 60 days after surgery]
  • Proctitis [Time frame: Six months after surgery]

Eligibility criteria

Inclusion criteria

  • Participants aged more than 18 years old.
  • Histological diagnosis of colorectal adenocarcinoma.
  • Participants scheduled for elective minimally invasive colorectal resection.
  • Participants with a preoperative MUST score equal to or below 2. Exclusion criteria
  • Any condition that, in the opinion of the investigator, may interfere with the study procedures.
  • Emergent surgery.
  • Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.
  • Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).
  • Participants with preoperative MUST score > 2.
  • Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Italy · 1 center
  • IRCCS Humanitas Research Hospital — Rozzano

Identifiers

NCT: NCT07599501 · CHR1-11-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗