Onset of Perineal Wound InfectionPhase 4NCT05297916
Delayed vs Early Enteral Feeding After Anterior Sagittal Anorectopexy
A Phase 4 study testing enteral feeding in people with Onset of Perineal Wound Infection, run by Tanta University at 1 site in Egypt.
Trial summary
to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Onset of Perineal Wound Infection
- What is being tested?
- enteral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2022to 2 Oct 2022
- Phase
- Phase 4
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All female infants with congenital rectoperineal fistula
Who cannot join
- patients with major anomalies, patients who have staged repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula
to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula
Read the detailed description
congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.
Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.
Patients and methods:
A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.
- Conditions
- Onset of Perineal Wound Infection
- Being tested
- enteral feeding
- Keywords
- recto-vestibular fistula,, early enteral feeding, peripheral parenteral nutrition, perineal wound infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral feedingOther
to intake oral feeding or delay it
| Study group | Role | What they receive |
|---|---|---|
| delayed enteral feeding | Active comparator | delayed enteral feeding Receives: Other: enteral feeding |
| early enteral feeding | Active comparator | early enteral feeding Receives: Other: enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal wound infection
the occurrence of wound infection after ASARP
Measured: WITHIN TWO WEEKS POST OPERATIVE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start2 Feb 2022
- Primary completion2 Aug 2022 (estimated)
- Study completion2 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onset of Perineal Wound InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- delayed enteral feeding ingroup 1 early enteral feeding in group 2
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297916
- Sponsor's protocol ID
- 35054/11/21
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Postoperative Enteral Feeding to Reduce the Incidence of Perineal Wound Infection Following Anterior Sagittal Anorectoplasty of Congenital Recto-vestibular Fistula
- ClinicalTrials.gov ID
- NCT05297916
- Acronym / sponsor ID
- 35054/11/21
- Conditions
- Onset of Perineal Wound Infection
- Keywords
- recto-vestibular fistula,, early enteral feeding, peripheral parenteral nutrition, perineal wound infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Aug 2022 (estimated)
- Study completion
- 2 Oct 2022 (estimated)
- First posted
- 28 Mar 2022 (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.
to study the effect of early vs delayed enteral feeding following ASARP in females with congenital recto-vestibular fistula
Detailed description
congenital Recto vestibular fistula represents the commonest type of anorectal malformation in females. The treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. Several perioperative factors may affect the outcome. One of major postoperative complications is the occurrence of wound infection.
Purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence.
Patients and methods:
A prospective randomized trial included 55 infants with recto-vestibular fistula. All infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. Patients were divided into two groups. group A included infants who started oral intake on the 5th postoperative day and group B included infants who started oral intake on the 2nd postoperative day. The primary outcome was the onset of perineal wound infection. Group A infants were kept on peripheral parenteral nutrition during fasting period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- delayed enteral feeding ingroup 1 early enteral feeding in group 2
| Arm | Type | Receives |
|---|---|---|
| delayed enteral feeding | Active comparator | Other: enteral feedingdelayed enteral feeding |
| early enteral feeding | Active comparator | Other: enteral feedingearly enteral feeding |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All female infants with congenital rectoperineal fistula
Key exclusion criteria (1 listed)
- patients with major anomalies, patients who have staged repair
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 |
|---|---|---|
| enteral feedingto intake oral feeding or delay it | Other | delayed enteral feeding, early enteral feeding |
Primary outcome
perineal wound infection
Time frame: WITHIN TWO WEEKS POST OPERATIVE
the occurrence of wound infection after ASARP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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 Phase 4 study testing enteral feeding in people with Onset of Perineal Wound Infection, run by Tanta University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
perineal wound infection (time frame: WITHIN TWO WEEKS POST OPERATIVE). 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 Mar 2022.