Optimizing Postoperative Nutrition in Colorectal Surgery

NCT06737211 | Completed

• 1 other identifier: OPTI-NUTRICS study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Diseases; Bowel Ischemia; Malnutrition; Parenteral Nutrition

Keywords

peripheral parenteral nutrition; postoperative outcomes; colorectal surgery; colorectal cancer; inflammatory bowel disease; bowel ischemia

Outcome Measures

Primary Outcomes (1)

• Postoperative Surgical Stress and Short-term Nutritional Status

  Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.

  5 postoperative days

Secondary Outcomes (6)

• Postoperative Morbidity

  90 postoperative days

• Nasogastric tube removal

  30 postoperative days

• Feeding start

  30 postoperative days

• Early mobilization

  30 postoperative days

• Opioid sparing analgesia

  30 postoperative days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Hippocration General Hospital of Athens

Athens, Greece

Location

Related Publications (5)

• Studer P, Raber G, Ott D, Candinas D, Schnuriger B. Risk factors for fatal outcome in surgical patients with postoperative aspiration pneumonia. Int J Surg. 2016 Mar;27:21-25. doi: 10.1016/j.ijsu.2016.01.043. Epub 2016 Jan 20.

  PMID: 26804349 BACKGROUND

• Herbert G, Perry R, Andersen HK, Atkinson C, Penfold C, Lewis SJ, Ness AR, Thomas S. Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications. Cochrane Database Syst Rev. 2019 Jul 22;7(7):CD004080. doi: 10.1002/14651858.CD004080.pub4.

  PMID: 31329285 BACKGROUND

• Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, Thevathasan T, Pieretti A, Ferrone C, Hoeft A, Scheeren TWL, Thompson BT, Kurth T, Eikermann M. Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study. Ann Surg. 2018 Jun;267(6):1084-1092. doi: 10.1097/SLA.0000000000002220.

  PMID: 28288059 BACKGROUND

• Cardinale F, Chinellato I, Caimmi S, Peroni DG, Franceschini F, Miraglia Del Giudice M, Bernardini R. Perioperative period: immunological modifications. Int J Immunopathol Pharmacol. 2011 Jul-Sep;24(3 Suppl):S3-12. doi: 10.1177/03946320110240s302.

  PMID: 22014920 BACKGROUND

• Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.

  PMID: 26248016 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases; Malnutrition; Hyperphagia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 17, 2024
• Study Start: December 1, 2024
• Primary Completion: August 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 6, 2026

Record last verified: 2024-12

Locations

GR (1)