Laparotomy Clinical Trial
— EATERSOfficial title:
Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial
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 30% 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.
Status | Recruiting |
Enrollment | 342 |
Est. completion date | January 1, 2026 |
Est. primary completion date | October 25, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 - Emergency primary midline laparotomy - Preoperative NRS-2002 (nutritional risk screening) score < 7 - No contraindications for oral or enteral nutrition after surgery - Unable to tolerate or take in at least 30% 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 - Non-midline incision - Laparoscopic procedure - Limiting mental or psychiatric disorders rendering participation unethical or unrealistic - Patients with a very limited expected remaining time of living (< 3 months) - Preoperative NRS-2002 = 7 - Pregnant or breastfeeding women - Refusal to participate - Emergency reoperations |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital at Herlev | Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious complications during admission | Rate of infectious complications during admission. The following infections will be registered: Urinary tract infections, pneumonia, bloodstream infections, surgical site infections, abdominal infections, and skin and soft tissue infections, | 1 week after hospital discharge | |
Secondary | Non-infectious complication rate during admission | Stratified by type and severity (Clavien-Dindo classification) | 1 week after hospital discharge | |
Secondary | Days with need for antibiotics | Days the participant received antibiotic treatment | 1 week after hospital discharge | |
Secondary | Length of stay | Time from admission to discharge | Up to 30 days | |
Secondary | Mortality rate (day 30, 90, and 180) | Mortality at day 30, 90, and 180 | Assessed 180 days after surgery | |
Secondary | Emergency readmission rate (day 30, 90, and 180) | Has the participant been re-admitted within 30, 90, or 180 days after surgery | Assessed 180 days after surgery | |
Secondary | Post-discharge nutritional status | SNAQ (Simplified Nutritional Appetite Questionnaire) screening tool and weight at day 30 and 90. A score between 5 and 20 is possible with a higher score being better. | Assessed at day 30 and 90 after surgery | |
Secondary | Post-discharge weight status | Weight at day 30 and 90 | Assessed at day 30 and 90 after surgery | |
Secondary | Routes of energy delivery | Oral intake, enteral intake, parenteral intake or a combination of the three | Up to two weeks | |
Secondary | Energy intake during admission | Measured in calories | Up to two weeks | |
Secondary | Protein intake during admission | Measured in grams of protein | Up to two weeks |
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