Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery

NCT07821138 | Not Yet Recruiting

• 1 other identifier: Children hospital Faisalabad
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study compares the Enhanced Recovery After Surgery (ERAS) protocol to traditional postoperative care in pediatric patients undergoing elective ileostomy reversal. The ERAS protocol uses a standardized approach to minimize surgical stress, lower complication rates, and improve recovery times. Participants are randomly assigned to either the ERAS protocol group or the traditional care group. The main goal of this study is to measure and compare the average length of post-operative hospital stay between the two groups. Additional outcomes evaluated include post-procedure pain scores, time to bladder catheter removal, duration of intravenous fluids, time to start oral feeding, and time to mobilization.

Conditions

Ileostomy - Stoma

Keywords

ERAS

Outcome Measures

Primary Outcomes (2)

• Length of Postoperative Hospital stay

  total duration of hospital stay recorded in days from the completion of surgery until discharge

  From date of surgery up to 30 days

• Length of postoperative Hospital Stay

  total duration of hospital stay recorded in days from the completion of surgery until discharge

  date of surgery up to 30 days

Study Arms (2)

Experimental: ERAS protocol

EXPERIMENTAL

Pediatric patients undergoing elective ileostomy reversal managed under the Enhanced Recovery After Surgery (ERAS) protocol, featuring early mobilization, early oral feeding, early catheter removal, and multimodal analgesia.

Other: ERAS protocol

Active comparator : Traditional care group

ACTIVE COMPARATOR

Pediatric patients undergoing elective ileostomy reversal managed under standard postoperative care routines, including traditional fasting periods, routine IV fluid management, and standard analgesia.

Other: Traditional care

Interventions

ERAS protocol OTHER

Enhanced Recovery After Surgery multimodal protocol involving early oral feeding, early catheter removal, early mobilization, and multimodal pain control Recovery after surgery

Experimental: ERAS protocol

Traditional care OTHER

Standard postoperative care protocol with conventional fasting, standard intravenous fluids, and routine pain management

Active comparator : Traditional care group

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients undergoing elective ileostomy reversal. Patients who previously had stoma formation for conditions such as Hirschsprung disease, necrotizing enterocolitis (NEC), or anorectal malformation (ARM).
• Written informed consent obtained from parent/guardian.

You may not qualify if:

• Emergency ileostomy reversal surgeries. Presence of severe systemic comorbidities or severe sepsis prior to surgery. Refusal to give consent.

Sponsors & Collaborators

• Children Hospital Faisalabad: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident surgeon

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09