Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorMichał Pasierbek
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients treated outside pediatric surgery departments
Patients requiring total parenteral nutrition prior to surgery
Emergency surgical procedures
Patients with Hirschsprung disease
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized Pediatric ERAS-Based Perioperative Protocol
Other interventionStandardized 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Standardized Pediatric ERAS-Based Perioperative ProtocolExperimental treatment 1 intervention
Group B: Conventional Perioperative Care (Historical Control)No intervention 0 interventions
Trial outcomes
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.
Time frame
From date of surgery to date of discharge during the index hospitalizationSecondary outcomes
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.
Time frame
From date of hospital admission to date of hospital discharge2
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.
Time frame
From date of surgery to first oral intake during the index hospitalization3
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.
Time frame
From date of surgery to achievement of tolerance of oral feeding during the index hospitalization4
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.
Time frame
Perioperative period, from preoperative preparation to discharge after the index hospitalizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michał Pasierbek
Lead sponsor
Medical University of Silesia
Sponsor institution
Source ClinicalTrials.gov