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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Diseases; Intestinal Resection
• Intervention / Treatment: Other: Standardized Pediatric ERAS-Based Perioperative Protocol

Detailed Description

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care strategy designed to reduce surgical stress, minimize postoperative complications, and accelerate recovery after major surgery. The concept was initially introduced by Henrik Kehlet in the late 1990s for patients undergoing colorectal surgery. The original "fast-track surgery" program included several key elements such as multimodal analgesia, avoidance of nasogastric tubes and abdominal drains, early postoperative oral feeding, early mobilization, and early removal of urinary catheters. These measures resulted in a significant reduction in postoperative length of hospital stay without increasing postoperative complications.

Subsequently, an international multidisciplinary working group led by Henrik Kehlet and Olle Ljungqvist further developed these concepts, leading to the creation of the ERAS protocol. Over the past two decades, ERAS protocols have been implemented across many surgical specialties and have consistently demonstrated improvements in postoperative outcomes, including reduced complication rates, shorter hospital stays, and faster return to normal activity. Traditional perioperative practices commonly used in surgery, such as prolonged preoperative fasting, routine mechanical bowel preparation, liberal intraoperative fluid administration, delayed postoperative feeding, routine use of nasogastric tubes and abdominal drains, and extensive use of opioid analgesia, have gradually been abandoned or significantly limited as evidence supporting ERAS principles accumulated.

Instead, ERAS protocols emphasize multimodal analgesia, early postoperative oral nutrition, optimized perioperative fluid management, early mobilization, and patient-centered perioperative education. Although ERAS protocols are widely implemented and well validated in adult surgery, their application in pediatric surgery remains limited. Pediatric ERAS pathways require modification because of the physiological and developmental differences of pediatric patients. Certain elements of adult ERAS protocols, such as routine thromboprophylaxis or intensive metabolic monitoring, are not routinely applicable in children. Nevertheless, preliminary studies have demonstrated that ERAS principles are safe and feasible in pediatric surgical populations.

Currently, perioperative care of children undergoing intestinal surgery in Poland varies considerably between centers, and standardized national guidelines have not yet been established. The aim of the present study is to evaluate the feasibility, safety, and clinical outcomes of a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. Patients with Hirschsprung disease will be excluded from the study because of the distinct pathophysiology of the disease, differences in surgical management, and specific postoperative recovery patterns, which could introduce significant heterogeneity and confound the evaluation of a standardized pediatric ERAS-based protocol in intestinal resection with primary anastomosis.

This multicenter study will be conducted in nine tertiary pediatric surgery centers in Poland. Due to the relatively small number of patients undergoing intestinal resection procedures in individual centers, a multicenter study design is necessary to achieve adequate statistical power. A total of 60 pediatric patients will be prospectively enrolled following implementation of the standardized pediatric ERAS-based protocol. The sample size includes an additional margin to account for potential dropouts. Outcomes in the ERAS cohort will be compared with a historical control group consisting of patients who underwent similar surgical procedures prior to the introduction of the ERAS protocol in the participating centers.

All participating centers will implement the same standardized pediatric ERAS-based protocol for children undergoing elective intestinal resection. Compliance with protocol elements will be monitored using a standardized checklist completed for each patient. Key components of the standardized pediatric ERAS-based protocol include comprehensive preoperative patient and caregiver education, nutritional assessment and optimization, avoidance of prolonged preoperative fasting, preoperative carbohydrate loading, multimodal opioid-sparing analgesia including regional anesthesia techniques, optimized intraoperative fluid management, maintenance of normothermia, minimization of invasive devices such as nasogastric tubes and abdominal drains, early removal of urinary catheters, early postoperative mobilization, and early initiation of oral feeding.

Postoperative pain will be assessed using age-appropriate validated scales, including the CHIPPS scale for children younger than five years, the Wong-Baker FACES Pain Rating Scale for children aged five to ten years, and the Visual Analogue Scale (VAS) for children older than ten years. The primary objective of the study is to assess the safety and feasibility of the standardized pediatric ERAS-based protocol in pediatric intestinal surgery. Secondary objectives include evaluation of postoperative recovery parameters, including length of hospital stay, postoperative complications, tolerance of early feeding, and postoperative pain control. The ultimate goal of this project is to generate high-quality multicenter evidence supporting the use of ERAS protocols in pediatric intestinal surgery and to contribute to the development of national perioperative care recommendations for children undergoing intestinal resection procedures in Poland.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michał J Pasierbek, M.D. Ph.D.; Phone Number: +48 500 089 727; Email: michal.pasierbek@sum.edu.pl
• Study Contact Backup: Name: Ewa Bieniek, M.D.; Phone Number: +48 606 695 204; Email: ewa@banka.pl

Study Locations

• Poland
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
      • Recruiting
      • Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology
      • Contact: Katarzyna Rasiewicz, M.D.; Phone Number: +48 71 736 49 00; Email: kswiatek@usk.wroc.pl
      • Contact: Monika Bukowska, M.D.; Phone Number: +48 71 736 49 00; Email: monika.bukowska125@gmail.com
      • Principal Investigator: Katarzyna Rasiewicz, M.D.
      • Sub-Investigator: Monika Bukowska, M.D.
      • Sub-Investigator: Dariusz Patkowski, Profesor
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-093
      • Recruiting
      • Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital
      • Contact: Anna Golonka, M.D. Ph.D.; Phone Number: ‭+48 880 050 838‬; Email: annagolonka007@gmail.com
      • Principal Investigator: Anna Golonka, M.D. Ph.D.
      • Sub-Investigator: Paweł Nachulewicz, Professor
      • Sub-Investigator: Michał Jędrejek, Trainee
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-091
      • Recruiting
      • University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics
      • Contact: Roksana Barglik, M.D. Ph.D; Phone Number: ‭+48 780 050 600‬; Email: roksana.barglik@gmail.com
      • Principal Investigator: Patrycja Sosnowska, M.D.Ph.D.
      • Sub-Investigator: Roksana Barglik, M.D.Ph.D.
      • Sub-Investigator: Marek Wolski, M.D. Ph.D.
      • Sub-Investigator: Ewa Biegańska, Trainee
  • Małopolska
    • Krakow, Małopolska, Poland, 30- 663
      • Recruiting
      • Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery
      • Contact: Joanna Godlewska, M.D.; Phone Number: +48 602 344 353; Email: jgodlewska@usdk.pl
      • Principal Investigator: Joanna Godlewska, M.D.
      • Sub-Investigator: Karolina Tokarska, M.D.
      • Sub-Investigator: Wojciech Górecki, Profesor
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80- 803
      • Recruiting
      • Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents
      • Contact: Stefan Anzelewicz, M.D.; Phone Number: +48 796 111 171; Email: stefan.anzelewicz@gmail.com
      • Principal Investigator: Stefan Anzelewicz, M.D. Ph.D.
      • Sub-Investigator: Tomasz Witowski, M.D.
      • Sub-Investigator: Piotr Czauderna, Profesor
      • Sub-Investigator: Andrzej Gołębiewski, M.D. Ph.D.
  • Upper Silesia
    • Zabrze, Upper Silesia, Poland, 41-800
      • Recruiting
      • Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology
      • Contact: Michał J Pasierbek, M.D. Ph.D.; Phone Number: +48 500 089 727; Email: michal.pasierbek@sum.edu.pl
      • Contact: Ewa Bieniek, Trainee; Phone Number: +48 606 695 204; Email: bankaewka@gmail.com
      • Principal Investigator: Michał J Pasierbek, M.D. Ph.D
      • Sub-Investigator: Wojciech A Korlacki, M.D. Ph.D.
      • Sub-Investigator: Ewa Bieniek, trainee
  • Warmian-Masurian Voivodeship
    • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-561
      • Recruiting
      • Regional Specialist Children's Hospital in Olsztyn, Poland. Clinical Department of Pediatric Surgery and Pediatric Urology with the Vascular Anomalies Treatment Center
      • Contact: Tomasz Janowicz, M.D. Ph.D.; Phone Number: +48 605 247 830; Email: tojanow@gmail.com
      • Principal Investigator: Michał Puliński, M.D. Ph.D.
      • Sub-Investigator: Tomasz Janowicz, M.D. Ph. D.
      • Sub-Investigator: Paulina Gisman, Trainee
  • Świętokrzyskie Voivodeship
    • Kielce, Świętokrzyskie Voivodeship, Poland, 25-317
      • Recruiting
      • Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology
      • Contact: Łukasz Władyszewski, M.D.; Phone Number: ‭+48 513 351 931‬; Email: wladyszewski.lukasz@gmail.com
      • Principal Investigator: Przemysław Wolak, M.D.Ph.D.
      • Sub-Investigator: Łukasz Władyszewski, M.D.
      • Sub-Investigator: Joanna Wróbel, Trainee
    • Rzeszów, Świętokrzyskie Voivodeship, Poland, 35-310
      • Recruiting
      • Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland
      • Contact: Anna Ogorzałek, M.D.; Phone Number: +48 600 946 655; Email: ogorzalki@poczta.fm
      • Principal Investigator: Anna Ogorzałek, M.D.
      • Sub-Investigator: Artur Szymczak, M.D. Ph.D.
      • Sub-Investigator: Sylwia Korczak, Trainee
      • Sub-Investigator: Jakub Żelazko, Trainee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized Pediatric ERAS-Based Perioperative Protocol; 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; 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.
No Intervention: Conventional Perioperative Care (Historical Control); Patients who previously underwent elective intestinal resection with primary anastomosis before implementation of the ERAS protocol in participating centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Total length of hospital stay, defined as the number of calendar days from hospital admission to hospital discharge during the index hospitalization.	From date of hospital admission to date of hospital discharge
Postoperative day of initiation of oral feeding	Postoperative day of first oral intake after the index surgery. The day of surgery is defined as postoperative day 0.	From date of surgery to first oral intake during the index hospitalization
Postoperative day of achievement of tolerance of oral feeding	Postoperative day of achievement of tolerance of oral feeding, defined as continuation of oral feeding without vomiting requiring treatment interruption, nasogastric decompression, or postoperative parenteral nutrition. The day of surgery is defined as postoperative day 0.	From date of surgery to achievement of tolerance of oral feeding during the index hospitalization
Proportion of protocol elements fulfilled per participant	Proportion of predefined elements of the standardized pediatric ERAS-based perioperative protocol fulfilled for each participant, assessed using the study checklist.	Perioperative period, from preoperative preparation to discharge after the index hospitalization
Postoperative parenteral nutrition requirement	Number of participants requiring postoperative parenteral nutrition during the index hospitalization. In the ERAS-based protocol, parenteral nutrition is not intended as routine postoperative support and is used only when oral or enteral feeding cannot be advanced because of delayed gastrointestinal recovery, clinically significant feeding intolerance, or postoperative complications.	From date of surgery to date of discharge during the index hospitalization
30-day postoperative complications	Number of participants with any postoperative complication occurring within 30 days after the index surgery, including surgical, infectious, gastrointestinal, urinary, bleeding-related, or other clinically documented complications.	Within 30 days after surgery
Major postoperative complications	Number of participants with major postoperative complications, defined as Clavien-Dindo grade IIIa or higher, within 30 days after surgery.	Within 30 days after surgery
30-day readmission	Number of participants requiring hospital readmission within 30 days after surgery.	Within 30 days after surgery
30-day unplanned reintervention or reoperation	Number of participants requiring unplanned reoperation, radiological intervention, endoscopic intervention, or other surgical intervention for a postoperative complication within 30 days after surgery.	Within 30 days after surgery
Surgical site infection, wound complication, or intra-abdominal abscess/collection	Number of participants with superficial incisional, deep incisional, or organ/space surgical site infection, wound complication, or intra-abdominal abscess/collection within 30 days after surgery.	Within 30 days after surgery
Anastomotic leak	Number of participants with confirmed or clinically suspected anastomotic leak within 30 days after surgery.	Within 30 days after surgery
Postoperative vomiting	Number of participants with documented postoperative vomiting or retching during the index hospitalization.	From date of surgery to date of discharge during the index hospitalization

Collaborators and Investigators

• Sponsor: Michał Pasierbek
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative care; Enhanced Recovery After Surgery; ERAS; Pediatric surgery; Intestinal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: ERAS_PED_RESECTION_2026; Ethics approval No (Other Identifier: Bioethics Committee Approval No. 5/2026, Jan Kochanowski University in Kielce)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No