Optimizing Postoperative Nutrition in Colorectal Surgery

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Bowel Ischemia; Malnutrition; Parenteral Nutrition

• Registration Number: NCT06737211
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Surgical Stress and Short-term Nutritional Status	5 postoperative days	Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hippocration General Hospital of Athens; 🇬🇷 Athens, Greece