Malignancies MultipleNCT07730333
The Frequency of Anastomotic Leakage in Early and Delayed Oral Feeding Following Ileostomy Reversal Will be Compared
A study testing Early oral feeding protocol and Delayed oral feeding protocol in people with Malignancies Multiple, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
The purpose of of this study is to compare the frequency of anastomotic leakage in early versus delayed oral feeding following feeding after illeostomy reversal so early oral feeding can be encouraged. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignancies Multiple
- What is being tested?
- Early oral feeding protocol and Delayed oral feeding protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective ileostomy reversal surgery
- age between 18 and 70 years
- patient provided informed consent
Who cannot join
- patients with active active peritonitis
- Advanced malignancy
- Patients requiring extensive bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Frequency of Anastomotic Leakage in Early Versus Delayed Oral Feeding After Illeostomy Reversal
The purpose of of this study is to compare the frequency of anastomotic leakage in early versus delayed oral feeding following feeding after illeostomy reversal so early oral feeding can be encouraged.
Read the detailed description
The purpose of of this study is to encourage early oral feeding after stoma reversal, shorten the length of hospitalisation and reduce post operative morbidity and mortality
- Conditions
- Malignancies Multiple
- Being tested
- Early oral feeding protocol, Delayed oral feeding protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral feeding protocolBehavioural
Patients receive oral liquids within or solid food within 24 hours after stoma reversal surgery
Delayed oral feeding protocolBehavioural
Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Early oral feeding | Experimental | Patients receive oral liquids within or solid food within 24 hours after stoma reversal reversal surgery Receives: Behavioral: Early oral feeding protocol |
| Group 2 : Delayed oral feeding | Active comparator | Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively Receives: Behavioral: Delayed oral feeding protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage 7 days after surgery
Measured: Within 14 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 Mar 2026
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancies MultipleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Dilshad, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730333
- Sponsor's protocol ID
- Ref No. 48.ERC/FMU/2025-26/247
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect patient confidentiality only aggregated study findings and statistical results will be made available through publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frequency of Anastomotic Leakage in Early Versus Delayed Oral Feeding After Illeostomy Reversal
- ClinicalTrials.gov ID
- NCT07730333
- Acronym / sponsor ID
- Ref No. 48.ERC/FMU/2025-26/247
- Conditions
- Malignancies Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 28 Jul 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.
The purpose of of this study is to compare the frequency of anastomotic leakage in early versus delayed oral feeding following feeding after illeostomy reversal so early oral feeding can be encouraged.
Detailed description
The purpose of of this study is to encourage early oral feeding after stoma reversal, shorten the length of hospitalisation and reduce post operative morbidity and mortality
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Early oral feeding | Experimental | Behavioral: Early oral feeding protocolPatients receive oral liquids within or solid food within 24 hours after stoma reversal reversal surgery |
| Group 2 : Delayed oral feeding | Active comparator | Behavioral: Delayed oral feeding protocolPatients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective ileostomy reversal surgery
- age between 18 and 70 years
- patient provided informed consent
Key exclusion criteria (3 listed)
- patients with active active peritonitis
- Advanced malignancy
- Patients requiring extensive bowel resection
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 |
|---|---|---|
| Early oral feeding protocolPatients receive oral liquids within or solid food within 24 hours after stoma reversal surgery | Behavioural | Group 1: Early oral feeding |
| Delayed oral feeding protocolPatients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively | Behavioural | Group 2 : Delayed oral feeding |
Primary outcome
Anastomotic leakage 7 days after surgery
Time frame: Within 14 days post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect patient confidentiality only aggregated study findings and statistical results will be made available through publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral feeding protocol and Delayed oral feeding protocol in people with Malignancies Multiple, run by Allied Hospital Faisalabad at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anastomotic leakage 7 days after surgery (time frame: Within 14 days post operatively). 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 28 Jul 2026.