Vestibular FistulaeVestibanusNCT04970160
Rectovestibular Fistula Which Surgical Approaches?
An observational study of Vestibular Fistulae, run by Aswan University Hospital.
Trial summary
This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, women only
- Conditions the study is for
- Vestibular Fistulae
- What is being tested?
- TSARP, PSARP and Classic ASARP
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 28 Feb 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 6 months to 12 years
- Women only
- No healthy volunteers
- Child
Study population: This study was a randomized, comparative trial involving female children suffering from vestibular fistula taken from among patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital from January 2016 to February 2020. The patients were randomly separated into four groups according to the procedure performed. The different procedures included were TSARP, PSARP, classic ASARP, and modified ASARP. Randomization did by copies the names of the techniques on four separate papers and then the surgeon was blindly chose one paper for each patient. Four pediatric surgeons had experience in ARMs techniques were performed the repair.
Who may be able to join
- Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.
Who cannot join
- Exclusion criteria were patients with recurrence, previous anorectal surgery.
- Patients with anovestibular fistulae.
- Patients with rectoperineal fistulas.
- Patients with cognitive impairment.
About this study
This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
Read the detailed description
Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
- Conditions
- Vestibular Fistulae
- Being tested
- TSARP, PSARP, Classic ASARP, Modified ASARP
- Keywords
- Vestibular anus,, Anal transposition,, Anorectal malformations, Transfistula anorectoplasty
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSARPProcedure or surgery
Also called Transfistula anorectoplasty TFARP
We make four different surgical operations for female patients with rectovestibular fistula
PSARPProcedure or surgery
Also called Posterior sagittal anorectoplasty
Posterior sagittal anorectoplasty
Classic ASARPProcedure or surgery
Also called Anterior Sagittal anorectoplasty
Anterior Sagittal anorectoplasty
Modified ASARPProcedure or surgery
Also called External anal sphincter preservation
External anal sphincter preservation
| Study group | Role | What they receive |
|---|---|---|
| TSARP | Is a surgical procedure Receives: Procedure: TSARP | |
| ASARP classic | Surgical procedure Receives: Procedure: Classic ASARP | |
| PSARP | Surgical procedure Receives: Procedure: PSARP | |
| Modified ASARP | Surgical procedure Receives: Procedure: Modified ASARP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Templeton score
The follow up period is up to one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score
. It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.
Measured: 1 year
Secondary outcomes (1)
Anal continence
The assessment period is upto one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score3
. It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2016
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular FistulaeStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy, Aswan University Hospital
- Investigators
- Sarah Abdelmohsen, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970160
- Sponsor's protocol ID
- AswanUH2
- Acronym
- Vestibanus
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectovestibular Fistula Which Surgical Approaches?
- ClinicalTrials.gov ID
- NCT04970160
- Acronym / sponsor ID
- Vestibanus / AswanUH2
- Conditions
- Vestibular Fistulae
- Keywords
- Vestibular anus,, Anal transposition,, Anorectal malformations, Transfistula anorectoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Jul 2021 (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 was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
Detailed description
Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The investigator compared four different operative techniques in terms of postoperative complications, continence, and cosmetic appearance. Patients and methods: This study was a prospective, randomized, comparative study that included female children with rectovestibular fistulae who were selected from patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital during the period from January 2016 to February 2020. The patients were randomly divided into four groups according to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TSARP | – | Procedure: TSARPIs a surgical procedure |
| ASARP classic | – | Procedure: Classic ASARPSurgical procedure |
| PSARP | – | Procedure: PSARPSurgical procedure |
| Modified ASARP | – | Procedure: Modified ASARPSurgical procedure |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study was a randomized, comparative trial involving female children suffering from vestibular fistula taken from among patients with anorectal malformations treated at the pediatric surgical unit, Assiut University Hospital from January 2016 to February 2020. The patients were randomly separated into four groups according to the procedure performed. The different procedures included were TSARP, PSARP, classic ASARP, and modified ASARP. Randomization did by copies the names of the techniques on four separate papers and then the surgeon was blindly chose one paper for each patient. Four pediatric surgeons had experience in ARMs techniques were performed the repair.
Key inclusion criteria (1 listed)
- Female children aged 6 months to 12 years who had rectovestibular fistulae that had been treated by a single-stage repair were included in this study.
Key exclusion criteria (4 listed)
- Exclusion criteria were patients with recurrence, previous anorectal surgery.
- Patients with anovestibular fistulae.
- Patients with rectoperineal fistulas.
- Patients with cognitive impairment.
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 |
|---|---|---|
| TSARPAlso: Transfistula anorectoplasty TFARPWe make four different surgical operations for female patients with rectovestibular fistula | Procedure or surgery | TSARP |
| PSARPAlso: Posterior sagittal anorectoplastyPosterior sagittal anorectoplasty | Procedure or surgery | PSARP |
| Classic ASARPAlso: Anterior Sagittal anorectoplastyAnterior Sagittal anorectoplasty | Procedure or surgery | ASARP classic |
| Modified ASARPAlso: External anal sphincter preservationExternal anal sphincter preservation | Procedure or surgery | Modified ASARP |
Primary outcome
Templeton score
Time frame: 1 year
The follow up period is up to one year. scheduled dilatation was followed. Data regarding early (up to 2 weeks) complications, such as wound infection, wound dehiscence, and skin excoriation, and delayed (one months to one year) complications, such as mucosal prolapse, fistula formation, and stenosis, were collected. The anorectal function was measured according to age of continence; younger children who had not attained the age of continence (<3.5 years) had the anocutaneous reflex and anal squeeze on rectal digital examination determined; children older than three and half years had fecal continence rated according to the Templeton score . It designates the operative outcome as "good," "fair," or "poor." The scoring performed prospectively during each follow up visit.
1 secondary outcome
Anal continence
Time frame: 1year
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 21 Jul 2021.
- Individual participant dataSharing planned: No
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.
Sarah Abdelmohsen principal investigator
Aswan University
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Fistulae, run by Aswan University Hospital.
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 4 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 21 Jul 2021. 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?
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?
Templeton score (time frame: 1 year). 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 21 Jul 2021.