Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 190
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.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 >
- •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.