Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery

Phase 1

Recruiting

• Conditions: Major emergency abdominal surgery; MedDRA version: 22.0Level: LLTClassification code: 10006055Term: Bowel obstruction Class: 10017947; MedDRA version: 21.1Level: PTClassification code: 10023696Term: Laparotomy Class: 100000004865; MedDRA version: 20.1Level: LLTClassification code: 10066720Term: Acute peritonitis Class: 10021881; MedDRA version: 20.0Level: LLTClassification code: 10021761Term: Infarction mesenteric Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-505378-14-00
• Lead Sponsor: Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Aged 18 or above, Primary emergency midline laparotomy, Preoperative NRS-2002 score < 7, No contraindications for oral or enteral intake after surgery, Intake of less than 30% of recommended caloric target on second postoperative day

Exclusion Criteria

Non-midline laparotomy, Refusal to participate in the study, Damage control laparotomy, Laparoscopic procedures, Remaining life expectancy < 3 months, Pregnant or breastfeeding women, Preoperative NRS-2002 score = 7, Limiting mental or psychiatric disorders rendering participation unethical or unrealistic, Emergency re-operation, Need for intensive care unit admission on second postoperative day, Need for parenteral nutrition before second postoperative day

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified