ClinicalTrials.gg
Not yet recruitingNCT07821138Updated Sep 17, 2026

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

An interventional study of ERAS protocol and Traditional care in Ileostomy - Stoma, sponsored by Children Hospital Faisalabad. Not yet recruiting. Open to participants aged 6 Months to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Children Hospital Faisalabad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
6 Months to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ileostomy - Stoma

Keywords

  • ERAS
03

In context

Lead sponsor

Children Hospital Faisalabad is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 obtained from parent/guardian.

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental: ERAS protocol

    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
    Active comparator : Traditional care group

    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

  • OtherERAS protocol

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

  • OtherTraditional care

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

06

What researchers measure

Primary outcomes

  1. Length of Postoperative Hospital stay

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

    Time frame: From date of surgery up to 30 days

  2. Length of postoperative Hospital Stay

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

    Time frame: date of surgery up to 30 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 15, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Apr 15, 2027
CompletionEst.
Apr 15, 2027
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07821138
Lead sponsor
Children Hospital Faisalabad
Responsible party
Nisar Ahmad (resident surgeon, Children Hospital Faisalabad) — Principal investigator
First posted
Sep 15, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
Apr 15, 2027 (estimated)
Last update
Sep 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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