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Nutritional Supplementation to Improve Colorectal Cancer Surgery

ConditionsColorectal CancerColorectal Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet Optimization (DO)

    Other intervention

    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.

  • Oral Nutritional Supplement (ONS)

    Dietary supplement

    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).

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Diet optimization (DO)Active comparator 1 intervention
Group B: Diet Optimization and Oral Nutritional Supplementation (DO+ONS)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative complications

The rate of postoperative complications occurring within 30 days from surgery

Time frame
30 days from surgery

Secondary outcomes

1

Postoperative septic complications

The rate of postoperative septic complications occurring within 30 days from surgery. Septic complications are defined according to the criteria proposed by the International Sepsis Definitions Conference and include documented postoperative extra-intestinal infections- such as urinary tract infections and pneumonia-, intra-abdominal septic complications- such as anastomotic leaks, pelvic abscesses, and peritonitis-, surgical site infections, and systemic symptoms of abnormal inflammatory response- such as fever higher than 38°C or C-Reactive Protein (CRP) increase higher than 200 mg/dL for more than two consecutive days

Time frame
30 days from surgery
2

Comprehensive Complication Index (CCI)

The median Comprehensive Complication Index (CCI) computed from all postoperative complications that occurred within 30 days from surgery. The CCI ranges from 0 to 100, where 0 indicates the best outcome (no postoperative complications), and 100 indicates the worst outcome (postoperative complications leading to death).

Time frame
30 days from surgery
3

Length of hospital stay

The median length of hospital stay calculated in days from the day after surgery until the day of discharge

Time frame
30 days from surgery
4

Hospital readmission

The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery

Time frame
30 days from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Clinico Humanitas

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: