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Intestinal DiseasesPeERASNCT07504549

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

A study testing Standardized Pediatric ERAS-Based Perioperative Protocol in people with Intestinal Diseases and Intestinal Resection, run by Michał Pasierbek at 9 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 to 17 years
Conditions the study is for
Intestinal Diseases, Intestinal Resection
What is being tested?
Standardized Pediatric ERAS-Based Perioperative Protocol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
9 sitesPoland
Study dates
1 Apr 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michał J Pasierbek, M.D. Ph.D. contact

+48 500 089 727

michal.pasierbek@sum.edu.pl

Ewa Bieniek, M.D. contact

+48 606 695 204

ewa@banka.pl

9 sites in 1 country

Poland9 sites, 9 recruiting
  • Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents

    Gdansk, Pomeranian Voivodeship, 80- 803

    Stefan Anzelewicz, M.D., +48 796 111 171, stefan.anzelewicz@gmail.com

    Stefan Anzelewicz, M.D. Ph.D.

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

    Kielce, Świętokrzyskie Voivodeship, 25-317

    Łukasz Władyszewski, M.D., ‭+48 513 351 931‬, wladyszewski.lukasz@gmail.com

    Przemysław Wolak, M.D.Ph.D.

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

    Krakow, Małopolska, 30- 663

    Joanna Godlewska, M.D., +48 602 344 353, jgodlewska@usdk.pl

    Joanna Godlewska, M.D.

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

    Lublin, Lublin Voivodeship, 20-093

    Anna Golonka, M.D. Ph.D., ‭+48 880 050 838‬, annagolonka007@gmail.com

    Anna Golonka, M.D. Ph.D.

    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

    Tomasz Janowicz, M.D. Ph.D., +48 605 247 830, tojanow@gmail.com

    Michał Puliński, M.D. Ph.D.

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

    Rzeszów, Świętokrzyskie Voivodeship, 35-310

    Anna Ogorzałek, M.D., +48 600 946 655, ogorzalki@poczta.fm

    Anna Ogorzałek, M.D.

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

    Warsaw, Masovian Voivodeship, 02-091

    Roksana Barglik, M.D. Ph.D, ‭+48 780 050 600‬, roksana.barglik@gmail.com

    Patrycja Sosnowska, M.D.Ph.D.

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

    Wroclaw, Lower Silesian Voivodeship, 50-556

    Katarzyna Rasiewicz, M.D., +48 71 736 49 00, kswiatek@usk.wroc.pl

    Monika Bukowska, M.D., +48 71 736 49 00, monika.bukowska125@gmail.com

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

    Zabrze, Upper Silesia, 41-800

    Michał J Pasierbek, M.D. Ph.D., +48 500 089 727, michal.pasierbek@sum.edu.pl

    Ewa Bieniek, Trainee, +48 606 695 204, bankaewka@gmail.com

    Recruiting

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
Standardized Pediatric ERAS-Based Perioperative Protocol
Keywords
ERAS, Enhanced Recovery After Surgery, Pediatric surgery, Intestinal resection, Perioperative care
Medical subject headings
Intestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07504549
Study groupRoleWhat they receive
Standardized Pediatric ERAS-Based Perioperative ProtocolExperimentalChildren undergoing elective intestinal resection with primary anastomosis managed according to a standardized pediatric ERAS-based perioperative protocol developed for this multicenter study.
Receives: Other: Standardized Pediatric ERAS-Based Perioperative Protocol
Conventional Perioperative Care (Historical Control)No interventionPatients who previously underwent elective intestinal resection with primary anastomosis before implementation of the ERAS protocol in participating centers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)
  1. 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.

    Measured: From date of hospital admission to date of hospital discharge

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: Within 30 days after surgery

  7. Major postoperative complications

    Number of participants with major postoperative complications, defined as Clavien-Dindo grade IIIa or higher, within 30 days after surgery.

    Measured: Within 30 days after surgery

  8. 30-day readmission

    Number of participants requiring hospital readmission within 30 days after surgery.

    Measured: Within 30 days after surgery

  9. 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.

    Measured: Within 30 days after surgery

  10. 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.

    Measured: Within 30 days after surgery

  11. Anastomotic leak

    Number of participants with confirmed or clinically suspected anastomotic leak within 30 days after surgery.

    Measured: Within 30 days after surgery

  12. Postoperative vomiting

    Number of participants with documented postoperative vomiting or retching during the index hospitalization.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504549
Sponsor's protocol ID
ERAS_PED_RESECTION_2026
Other IDs
Ethics approval No
Acronym
PeERAS
Status last verified
Mar 2026
First submitted
21 Mar 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Pediatric ERAS-Based Perioperative Protocol in people with Intestinal Diseases and Intestinal Resection, run by Michał Pasierbek at 9 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michał J Pasierbek, M.D. Ph.D. (+48 500 089 727, michal.pasierbek@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative day of discharge (time frame: From date of surgery to date of discharge during the index hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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