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NOT YET RECRUITING
NCT07504549
NA

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

Sponsor: Michał Pasierbek

View on ClinicalTrials.gov

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.

Official title: Implementation of a Standardized Pediatric ERAS-Based Protocol in Children Undergoing Elective Segmental Intestinal Resection With Primary Anastomosis: A Multicenter Prospective Study

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-04

Completion Date

2028-07

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (9)

Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology

Wroclaw, Lower Silesian Voivodeship, Poland

Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital

Lublin, Lublin Voivodeship, Poland

University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics

Warsaw, Masovian Voivodeship, Poland

Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery

Krakow, Małopolska, Poland

Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents

Gdansk, Pomeranian Voivodeship, Poland

Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology

Zabrze, Upper Silesia, Poland

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

Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology

Kielce, Świętokrzyskie Voivodeship, Poland

Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland

Rzeszów, Świętokrzyskie Voivodeship, Poland