NCT07504549 Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis
| NCT ID | NCT07504549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michał Pasierbek |
| Condition | Intestinal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-04-01 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michal Pasierbek, M.D. Ph.D.
PRINCIPAL INVESTIGATOR
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800
Frequently Asked Questions
Who can join the NCT07504549 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying Intestinal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07504549 currently recruiting?
Yes, NCT07504549 is actively recruiting participants. Contact the research team at michal.pasierbek@sum.edu.pl for enrollment information.
Where is the NCT07504549 trial being conducted?
This trial is being conducted at Wroclaw, Poland, Lublin, Poland, Warsaw, Poland, Krakow, Poland and 5 additional locations.
Who is sponsoring the NCT07504549 clinical trial?
NCT07504549 is sponsored by Michał Pasierbek. The principal investigator is Michal Pasierbek, M.D. Ph.D. at Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800. The trial plans to enroll 120 participants.