Actively Recruiting

Phase Not Applicable
Age: 0Years - 17Years
All Genders
ID07504549

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

Age: 0Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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

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