Ileostomy - StomaNCT05680428
Early Feeding Versus Conventional Feeding
A study testing early feeding and conventional feeding in people with Ileostomy - Stoma, run by DHQ mardan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are: whether it is beneficial to start oral feeding within 12hrs after stoma reversal Participants will be randomly assigned two groups either early feeding or conventional group Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- early feeding and conventional feeding
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2020to 10 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having ileostomy
- no peritonitis
- intestinal obstruction
Who cannot join
- uncontrolled diabetes
- uncontrolled hypertension
- sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Early Feeding Versus Conventional Feeding After Stoma Reversal in Adult Surgical Surgical Practices
The goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are:
- whether it is beneficial to start oral feeding within 12hrs after stoma reversal
Participants will be randomly assigned two groups either early feeding or conventional group
- Conditions
- Ileostomy - Stoma
- Being tested
- early feeding, conventional feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early feedingOther
oral feeding within 12hours after stoma reversal
conventional feedingProcedure or surgery
oral feeding after 48hours of NBM after stoma reversal
| Study group | Role | What they receive |
|---|---|---|
| early feeding group | Experimental | after stoma reversal in patients in this group oral feeding was started with in 12 hrs after surgery Receives: Other: early feeding |
| conventional feeding group | Active comparator | after stoma reversal in patients in this group oral feeding was started 48hrs after surgery Receives: Procedure: conventional feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus
comparison of post-op anastomotic leakage hospital stay wound infection
Measured: 5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start10 Jan 2020
- Primary completion10 Jun 2022
- Study completion10 Jul 2022
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- DHQ mardan
- Sponsor type
- University, hospital or other
- Collaborators
- DHQ HOSPITAL MARDAN
- Responsible party
- Principal investigator, Sajid Ali,FCPS, DHQ mardan
- Investigators
- sajid khan, fcps, Principal investigator, DHQ mardan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680428
- Sponsor's protocol ID
- 278-41
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Feeding Versus Conventional Feeding After Stoma Reversal in Adult Surgical Surgical Practices
- ClinicalTrials.gov ID
- NCT05680428
- Acronym / sponsor ID
- 278-41
- Conditions
- Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- DHQ mardanUniversity, hospital or other
- Collaborators
- DHQ HOSPITAL MARDAN
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 11 Jan 2023 (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 goal of this clinical trial is to compare early feeding vs conventional feeding after stoma reversal. The main question it aims to answer are:
- whether it is beneficial to start oral feeding within 12hrs after stoma reversal
Participants will be randomly assigned two groups either early feeding or conventional group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early feeding group | Experimental | Other: early feedingafter stoma reversal in patients in this group oral feeding was started with in 12 hrs after surgery |
| conventional feeding group | Active comparator | Procedure: conventional feedingafter stoma reversal in patients in this group oral feeding was started 48hrs after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having ileostomy
- no peritonitis
- intestinal obstruction
Key exclusion criteria (3 listed)
- uncontrolled diabetes
- uncontrolled hypertension
- sepsis
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 feedingoral feeding within 12hours after stoma reversal | Other | early feeding group |
| conventional feedingoral feeding after 48hours of NBM after stoma reversal | Procedure or surgery | conventional feeding group |
Primary outcome
To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus
Time frame: 5days
comparison of post-op anastomotic leakage hospital stay wound infection
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 18 Jan 2023.
- Individual participant dataSharing planned: No
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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.
sajid khan, fcps principal investigator
DHQ mardan
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 feeding and conventional feeding in people with Ileostomy - Stoma, run by DHQ mardan 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 18 Jan 2023. 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?
To evaluate the outcome of early versus conventional oral feeding in stoma reversal in terms of postoperative ileus (time frame: 5days). 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 18 Jan 2023.