Ileostomy - StomaNCT07821138
Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery
A study testing ERAS protocol and Traditional care in people with Ileostomy - Stoma, run by Children Hospital Faisalabad.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- ERAS protocol and Traditional care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Apr 2027
- 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 6 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Emergency ileostomy reversal surgeries. Presence of severe systemic comorbidities or severe sepsis prior to surgery. Refusal to give consent.
About this study
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
- Being tested
- ERAS protocol, Traditional care
- Keywords
- ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolOther
Enhanced Recovery After Surgery multimodal protocol involving early oral feeding, early catheter removal, early mobilization, and multimodal pain control Recovery after surgery
Traditional careOther
Standard postoperative care protocol with conventional fasting, standard intravenous fluids, and routine pain management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Postoperative Hospital stay
total duration of hospital stay recorded in days from the completion of surgery until discharge
Measured: 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
Measured: date of surgery up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisar Ahmad, Children Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821138
- Sponsor's protocol ID
- Children hospital Faisalabad
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery
- ClinicalTrials.gov ID
- NCT07821138
- Acronym / sponsor ID
- Children hospital Faisalabad
- Conditions
- Ileostomy - Stoma
- Keywords
- ERAS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children Hospital FaisalabadUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: ERAS protocol | Experimental | Other: ERAS protocolPediatric 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. |
| Active comparator : Traditional care group | Active comparator | Other: Traditional carePediatric patients undergoing elective ileostomy reversal managed under standard postoperative care routines, including traditional fasting periods, routine IV fluid management, and standard analgesia. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Emergency ileostomy reversal surgeries. Presence of severe systemic comorbidities or severe sepsis prior to surgery. Refusal to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolEnhanced Recovery After Surgery multimodal protocol involving early oral feeding, early catheter removal, early mobilization, and multimodal pain control Recovery after surgery | Other | Experimental: ERAS protocol |
| Traditional careStandard postoperative care protocol with conventional fasting, standard intravenous fluids, and routine pain management | Other | Active comparator : Traditional care group |
Primary outcome
Length of Postoperative Hospital stay
Time frame: From date of surgery up to 30 days
total duration of hospital stay recorded in days from the completion of surgery until discharge
Length of postoperative Hospital Stay
Time frame: date of surgery up to 30 days
total duration of hospital stay recorded in days from the completion of surgery until discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol and Traditional care in people with Ileostomy - Stoma, run by Children Hospital Faisalabad.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Postoperative Hospital stay (time frame: From date of surgery up to 30 days). The study lists 2 primary outcomes in all. 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 17 Sep 2026.