Optimizing Postoperative Nutrition in Colorectal Surgery (OPTI-NUTRICS)

January 3, 2026 updated by: Maximos Frountzas, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Hippocration General Hospital of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Colorectal resection surgery
  • Open or laparoscopic procedures
  • Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection
  • Elective or emergent procedures
  • Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia
  • Small bowel resection combined with colorectal resection
  • Age > 18 years old
  • Informed consent

Exclusion Criteria:

  • Small bowel resection without colorectal resection
  • End-stoma or defunctioning stoma formation without colorectal resection
  • Preoperative parenteral nutrition administration
  • Administration of parenteral nutrition after the 4th postoperative day
  • Peripheral parenteral nutrition initiation after the 1st postoperative day
  • Contraindication for peripheral parenteral nutrition administration
  • Age < 18 years old
  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
2000 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
Dietary supplement: Peripheral Parenteral Nutrition
2000 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
No Intervention: Control
1000 mL of 10% glucose saline with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a central or peripheral venous catheter with a rhythm of 80cc/h until the 5th postoperative day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Surgical Stress and Short-term Nutritional Status
Time Frame: 5 postoperative days
Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.
5 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Morbidity
Time Frame: 90 postoperative days
Complications after surgery and their classification according to Calvin-Dindo score.
90 postoperative days
Nasogastric tube removal
Time Frame: 30 postoperative days
Postoperative day of nasogastric tube removal
30 postoperative days
Feeding start
Time Frame: 30 postoperative days
Postoperative day of feeding start
30 postoperative days
Early mobilization
Time Frame: 30 postoperative days
Postoperative day of mobilization
30 postoperative days
Opioid sparing analgesia
Time Frame: 30 postoperative days
Utilization of epidural sparing catheter
30 postoperative days
Peripheral Parenteral Nutrition - associated complications
Time Frame: 30 postoperative days
Thrombophlebitis, hyperglycemia, re-feeding syndrome
30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

August 20, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTI-NUTRICS study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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