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NCT06089551
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Conditions: Laparotomy, Bowel Obstruction, Ischemia, Mesenteric
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 342
Sponsor: Copenhagen University Hospital at Herlev
Location: Herlev Hospital Herlev
Summary
The aim of this study is to investigate the effect of early, supplementary parenteral nutrition following emergency laparotomy.
Currently, parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible. However, little data exists on the optimal timing of parenteral nutrition.
Oral and enteral nutrition is encouraged. Participants will randomized on the second postoperative day if their calorie intake (oral + enteral) is below 50% of the calculated requirement. Patients will be randomized to early (postoperative day 2) or postponed (postoperative day 5) start of parenteral nutrition.
The combined oral + enteral + parenteral calorie target is 70-80% of the calculated requirement. Participants in the postponed group will be re-assessed on postoperative day 5, and if their calorie intake is less than 50% parenteral nutrition will be administered.
The intervention will continue until oral + enteral intake is at least 70% of the calculated requirement or the participant is at his/her habitual intake.
Eligibility Criteria
Inclusion Criteria:
* Age \> 18
* Emergency primary midline laparotomy or laparoscopy
* NRS-2002 (nutritional risk screening) score \< 7
* No contraindications for oral or enteral nutrition after surgery
* Unable to tolerate or take in at least 50% of calculated calorie requirement on postoperative day 2
* Capable of providing informed consent at the time of inclusion
Exclusion Criteria:
* Laparotomy without closure of the abdominal aponeurosis
* Laparoscopic appendectomy or cholecystectomy as the procedure
* Limiting mental or psychiatric disorders rendering participation unethical or unrealistic
* Patients with a very limited expected remaining time of living (\< 3 months)
* NRS-2002 = 7
* Pregnant or breastfeeding women
* Refusal to participate
Source: ClinicalTrials.gov (NCT06089551). StuddyBuddy aggregates publicly available trial information.