Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery (NCT06089551) | Clinical Trial Compass
UnknownPhase 4
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Denmark342 participantsStarted 2023-10-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.