Actively Recruiting
Implementation of a Standardized Pediatric ERAS-Based Protocol in Children Undergoing Elective Intestinal Resection With Primary Anastomosis: A Multicenter Prospective Study
Led by Michał Pasierbek · Updated on 2026-06-02
120
Participants Needed
9
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Enhanced Recovery After Surgery (ERAS) is a care approach used during the period surrounding surgery to reduce stress, lower complications, and speed recovery. While ERAS is common in adult surgeries, its use in children, especially for intestinal surgery, is limited and lacks standardized guidelines. This multicenter prospective study in Poland aims to assess the safety, feasibility, and outcomes of a pediatric ERAS protocol in children undergoing elective intestinal resection with primary anastomosis, excluding those with Hirschsprung disease due to their unique conditions. The study involves 60 children treated in nine pediatric surgery centers, all managed under the same standardized ERAS protocol. This protocol includes preoperative education, nutritional assessment, reduced fasting, preoperative carbohydrate loading, multimodal pain control including regional anesthesia, optimized fluid management during surgery, minimal use of devices like tubes and drains, early removal of catheters, early mobilization, and early oral feeding. Patients managed with this protocol will be compared to a historical group treated before ERAS implementation. Participants will be closely monitored for adherence to the protocol and evaluated using age-appropriate pain scales. Researchers will track various outcomes such as length of hospital stay, timing of oral feeding, postoperative complications, pain control, and readmissions within 30 days. The study aims to provide strong evidence to support pediatric ERAS use and help create national care guidelines for children undergoing intestinal surgery in Poland.
CONDITIONS
Brief Title
Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients younger than 18 years
- Patients undergoing elective intestinal resection with primary anastomosis
- Patients treated in participating pediatric surgery departments
- Patients managed according to the standardized pediatric ERAS-based protocol after its implementation in participating centers
You will not qualify if you...
- Patients treated outside pediatric surgery departments
- Patients requiring total parenteral nutrition prior to surgery
- Emergency surgical procedures
- Patients with Hirschsprung disease
- Resection with stoma formation, or creation of a protective/diverting stoma during the index operation
- Patients with incomplete clinical data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay post-surgery
Participants undergo elective intestinal resection with primary anastomosis and receive care according to the standardized pediatric ERAS-based protocol, including multimodal analgesia, optimized fluid management, and early postoperative oral feeding and mobilization.
Hospital stay visits
Duration - Up to 30 days after surgery
Participants are monitored for post-operative recovery including complications, tolerance of oral feeding, pain control, and hospital discharge readiness.
Follow-up visits during hospitalization and up to 30 days post-surgery
Trial Site Locations
Total: 9 locations
1
Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
2
Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital
Lublin, Lublin Voivodeship, Poland, 20-093
Actively Recruiting
3
University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics
Warsaw, Masovian Voivodeship, Poland, 02-091
Actively Recruiting
4
Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery
Krakow, Małopolska, Poland, 30- 663
Actively Recruiting
5
Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents
Gdansk, Pomeranian Voivodeship, Poland, 80- 803
Actively Recruiting
6
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology
Zabrze, Upper Silesia, Poland, 41-800
Actively Recruiting
7
Regional Specialist Children's Hospital in Olsztyn, Poland. Clinical Department of Pediatric Surgery and Pediatric Urology with the Vascular Anomalies Treatment Center
Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-561
Actively Recruiting
8
Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology
Kielce, Świętokrzyskie Voivodeship, Poland, 25-317
Actively Recruiting
9
Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland
Rzeszów, Świętokrzyskie Voivodeship, Poland, 35-310
Actively Recruiting
Research Team
M
Michał J Pasierbek, M.D. Ph.D.
E
Ewa Bieniek, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here