NCT07504549

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Jul 2028

First Submitted

Initial submission to the registry

March 21, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 21, 2026

Last Update Submit

May 30, 2026

Conditions

Intestinal DiseasesIntestinal Resection

Keywords

ERASEnhanced Recovery After SurgeryPediatric surgeryIntestinal resectionPerioperative care

Outcome Measures

Primary Outcomes (1)

  • Postoperative day of discharge

    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.

    From date of surgery to date of discharge during the index hospitalization

Secondary Outcomes (12)

  • Length of hospital stay

    From date of hospital admission to date of hospital discharge

  • Postoperative day of initiation of oral feeding

    From date of surgery to first oral intake during the index hospitalization

  • Postoperative day of achievement of tolerance of oral feeding

    From date of surgery to achievement of tolerance of oral feeding during the index hospitalization

  • Proportion of protocol elements fulfilled per participant

    Perioperative period, from preoperative preparation to discharge after the index hospitalization

  • Postoperative parenteral nutrition requirement

    From date of surgery to date of discharge during the index hospitalization

  • +7 more secondary outcomes

Study Arms (2)

Standardized Pediatric ERAS-Based Perioperative Protocol

EXPERIMENTAL

Children undergoing elective intestinal resection with primary anastomosis managed according to a standardized pediatric ERAS-based perioperative protocol developed for this multicenter study.

Other: Standardized Pediatric ERAS-Based Perioperative Protocol

Conventional Perioperative Care (Historical Control)

NO INTERVENTION

Patients who previously underwent elective intestinal resection with primary anastomosis before implementation of the ERAS protocol in participating centers.

Interventions

Standardized Pediatric ERAS-Based Perioperative ProtocolOTHER

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.

Standardized Pediatric ERAS-Based Perioperative Protocol

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

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

Lublin, Lublin Voivodeship, 20-093, Poland

RECRUITING

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

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

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

Krakow, Małopolska, 30- 663, Poland

RECRUITING

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

Gdansk, Pomeranian Voivodeship, 80- 803, Poland

RECRUITING

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

Zabrze, Upper Silesia, 41-800, Poland

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, 10-561, Poland

RECRUITING

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

Kielce, Świętokrzyskie Voivodeship, 25-317, Poland

RECRUITING

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

Rzeszów, Świętokrzyskie Voivodeship, 35-310, Poland

RECRUITING

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Michal Pasierbek, M.D. Ph.D.

    Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał J Pasierbek, M.D. Ph.D.

CONTACT

+48 500 089 727michal.pasierbek@sum.edu.pl

Ewa Bieniek, M.D.

CONTACT

+48 606 695 204ewa@banka.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Blinding is not feasible due to the nature of the ERAS perioperative protocol and surgical care.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective multicenter cohort study evaluating the implementation of a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. Outcomes in the ERAS cohort will be compared with those of a historical control group treated before ERAS implementation in participating centers.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Assistant, Department of Pediatric Surgery

Study Record Dates

First Submitted

March 21, 2026

First Posted

April 1, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this is a multicenter academic study involving pediatric patients, and no formal data-sharing agreement has been established among the participating centers.

Locations

PL(9)