Clinical Trials Directory

Trials / Completed

CompletedNCT06737211

Optimizing Postoperative Nutrition in Colorectal Surgery

Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200 (actual)
Sponsor
National and Kapodistrian University of Athens · Academic / Other
Sex
All
Age
18 Years – 95 Years
Healthy volunteers
Not accepted

Summary

Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPeripheral Parenteral Nutrition2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day

Timeline

Start date
2024-12-01
Primary completion
2025-08-20
Completion
2025-11-20
First posted
2024-12-17
Last updated
2026-01-06

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT06737211. Inclusion in this directory is not an endorsement.