RecruitingNot ApplicableNCT07504549

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

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

Sponsor

Michał Pasierbek

Enrollment

120 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Intestinal Diseases Intestinal Resection

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

Min Age: 0 YearsMax Age: 17 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

OTHERStandardized 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

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NCT07504549