Comparing early and delayed parenteral nutrition after emergency abdominal surgery
Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial
This study is testing whether starting nutrition support right after emergency abdominal surgery helps patients recover better than waiting a few days to start it.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06089551 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of early versus postponed supplementary parenteral nutrition in patients who have undergone emergency laparotomy. Participants will be randomized on the second postoperative day based on their calorie intake, with one group receiving parenteral nutrition immediately and the other starting it on the fifth postoperative day if their intake remains insufficient. The goal is to achieve a combined calorie intake of 70-80% of the calculated requirement through oral, enteral, and parenteral means. The study aims to determine the optimal timing for initiating parenteral nutrition to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone emergency midline laparotomy or laparoscopy and are unable to meet their caloric needs postoperatively.
Not a fit: Patients who have contraindications for oral or enteral nutrition or those with a very limited expected remaining time of living may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize nutritional support for patients recovering from major abdominal surgery, potentially leading to better recovery outcomes.
How similar studies have performed: While there is limited data on the optimal timing of parenteral nutrition, similar studies have shown varying results, indicating that this approach may provide new insights into nutritional management post-surgery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev
- Herlev Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Jannick B Hansen, M.D. — Copenhagen University Hospital at Herlev
- Study coordinator: Jannick B Hansen, M.D.
- Email: jannick.brander.hansen@regionh.dk
- Phone: +4538686862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.