Optimizing Postoperative Nutrition in Colorectal Surgery (OPTI-NUTRICS)

National and Kapodistrian University of Athens

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Peripheral Parenteral Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06737211

OPTI-NUTRICS study

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Peripheral Parenteral Nutrition

Control

No Intervention group

Description:

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