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Recruiting Not applicable

Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis

NCT07504549 · tracked via the Priya Life Science Poland tracker
Sponsor
Michał Pasierbek
Phase
Not applicable
Started
2026-04-01
Last updated
2026-06-02

Condition(s) studied

Intestinal DiseasesIntestinal Resection

Investigational drug(s) / intervention(s)

Standardized Pediatric ERAS-Based Perioperative Protocol

Standardized Pediatric ERAS-Based Perioperative Protocol: Standardized pediatric ERAS-based perioperative care pathway developed for this multicenter study in children undergoing elective intestinal resection with primary anastomosis. The protocol includes preoperative counseling, nutritional assessment, reduced fasting, carbohydrate loading, multimodal analgesia with regional anesthesia, optimized intraoperative fluid management, early mobilization, and early postoperative oral feeding.

Study summary

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care strategy designed to reduce surgical stress, decrease postoperative complications, and accelerate recovery after surgery. Although ERAS protocols are widely implemented in adult surgery, their application in pediatric surgery remains limited, and standardized perioperative guidelines for children undergoing intestinal surgery have not yet been fully established. This multicenter prospective study aims to evaluate the feasibility, safety, and clinical outcomes of implementing a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis.

The study will be conducted in nine tertiary pediatric surgery centers in Poland. A total of 60 pediatric patients will be prospectively enrolled and managed according to the ERAS protocol. Outcomes in this cohort will be compared with a historical control group consisting of patients who underwent similar procedures before ERAS implementation. The primary research question is whether implementation of an ERAS protocol in pediatric intestinal surgery is safe and feasible and whether it improves postoperative recovery compared with conventional perioperative care. The study will evaluate perioperative outcomes including postoperative complications, length of hospital stay, tolerance of early oral feeding, and postoperative pain control.

Eligibility

Sex
ALL
Min age
0 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Postoperative day of discharge — From date of surgery to date of discharge during the index hospitalization
    Postoperative day of discharge, defined as the number of postoperative calendar days from the index intestinal resection with primary anastomosis to hospital discharge. The day of surgery is defined as postoperative day 0.

Trial sites (9)

FacilityCityRegionStatus
Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology Wroclaw Lower Silesian Voivodeship Recruiting
Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital Lublin Lublin Voivodeship Recruiting
University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics Warsaw Masovian Voivodeship Recruiting
Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery Krakow Małopolska Recruiting
Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents Gdansk Pomeranian Voivodeship Recruiting
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology Zabrze Upper Silesia Recruiting
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 Recruiting
Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology Kielce Świętokrzyskie Voivodeship Recruiting
Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland Rzeszów Świętokrzyskie Voivodeship Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07504549 on ClinicalTrials.gov ↗ ← All trials in Poland