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Completed

NCT Number: NCT06737211

Optimizing Postoperative Nutrition in Colorectal Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral Parenteral Nutrition

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Morbidity

    Time frame: 90 postoperative days

    Complications after surgery and their classification according to Calvin-Dindo score.

  2. Nasogastric tube removal

    Time frame: 30 postoperative days

    Postoperative day of nasogastric tube removal

  3. Feeding start

    Time frame: 30 postoperative days

    Postoperative day of feeding start

  4. Early mobilization

    Time frame: 30 postoperative days

    Postoperative day of mobilization

  5. Opioid sparing analgesia

    Time frame: 30 postoperative days

    Utilization of epidural sparing catheter

  6. Peripheral Parenteral Nutrition - associated complications

    Time frame: 30 postoperative days

    Thrombophlebitis, hyperglycemia, re-feeding syndrome

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Acronym: OPTI-NUTRICS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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