Clinical trial · Interventional
Nutritional Supplementation to Improve Colorectal Cancer Surgery
Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial
NCT07599501CI-TRIAL-00112164NUTRICOLORnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet Optimization (DO) | Other | — | UNRESOLVED |
| Oral Nutritional Supplement (ONS) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diet optimization (DO)
- description
- 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.
- interventionNames
- Other: Diet Optimization (DO)
- type
- EXPERIMENTAL
- label
- Diet Optimization and Oral Nutritional Supplementation (DO+ONS)
- description
- Participants in the DO+ONS arm will receive dietary optimization and standardized oral nutritional supplementation designed according to the ESPEN guidelines. The treatment will start 14 days before surgery and will be restored the day after surgery for the following 60 days.
- interventionNames
- Other: Diet Optimization (DO)
- Dietary Supplement: Oral Nutritional Supplement (ONS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.