Optimizing Postoperative Nutrition in Colorectal Surgery

NCT ID: NCT06737211

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Peripheral Parenteral Nutrition

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Maximos Frountzas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hippocration General Hospital of Athens

Athens, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 26804349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31329285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28288059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22014920 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 26248016 (View on PubMed)

Other Identifiers

OPTI-NUTRICS study

Identifier Type: -

Identifier Source: org_study_id