Fistula in AnoNCT05660876
Fistulotomy Versus Fistulotomy With Marsupialization
A study testing standard fistulotomy and fistulotomy with marsupialization in people with Fistula in Ano, run by DHQ mardan at 1 site in Pakistan.
Trial summary
It was a study comparing two standard procedures for fistula in ano Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- standard fistulotomy and fistulotomy with marsupialization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2020to 30 Sep 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having low lying anal fistula Willing to enroll in study
Who cannot join
- unfit pts Having uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial
It was a study comparing two standard procedures for fistula in ano
Read the detailed description
It was a study which compared two standard surgical procedures for fistula in ano
- Conditions
- Fistula in Ano
- Being tested
- standard fistulotomy, fistulotomy with marsupialization
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard fistulotomyProcedure or surgery
in a standard manner fistula tract was identified and laid open without doing marsupialization
fistulotomy with marsupializationProcedure or surgery
in this arm fistulotomy was done in a standard manner and marsupialization was done
| Study group | Role | What they receive |
|---|---|---|
| Fistulotomy | Other | Standard fistulotomy was done in this arm Receives: Procedure: standard fistulotomy; Procedure: fistulotomy with marsupialization |
| Fistulotomy with marsupialization | Other | This arm consists of fistulotomy in which marsupialization was done Receives: Procedure: standard fistulotomy; Procedure: fistulotomy with marsupialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of healing time in fistula in ano with and without marsupialization
We measured the healing time between two groups
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 Dec 2022
- Study start1 Aug 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DHQ mardan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sajid Ali,FCPS, DHQ mardan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660876
- Sponsor's protocol ID
- 188-40
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 21 Dec 2022
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistulotomy Versus Fistulotomy With Marsupialization, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05660876
- Acronym / sponsor ID
- 188-40
- Conditions
- Fistula in Ano
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DHQ mardanUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Dec 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.
It was a study comparing two standard procedures for fistula in ano
Detailed description
It was a study which compared two standard surgical procedures for fistula in ano
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fistulotomy | Other | Procedure: standard fistulotomy, Procedure: fistulotomy with marsupializationStandard fistulotomy was done in this arm |
| Fistulotomy with marsupialization | Other | Procedure: standard fistulotomy, Procedure: fistulotomy with marsupializationThis arm consists of fistulotomy in which marsupialization was done |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- having low lying anal fistula Willing to enroll in study
Key exclusion criteria (1 listed)
- unfit pts Having uncontrolled diabetes
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 |
|---|---|---|
| standard fistulotomyin a standard manner fistula tract was identified and laid open without doing marsupialization | Procedure or surgery | Fistulotomy, Fistulotomy with marsupialization |
| fistulotomy with marsupializationin this arm fistulotomy was done in a standard manner and marsupialization was done | Procedure or surgery | Fistulotomy, Fistulotomy with marsupialization |
Primary outcome
Comparison of healing time in fistula in ano with and without marsupialization
Time frame: 1year
We measured the healing time between two groups
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 Dec 2022.
- 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.
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 standard fistulotomy and fistulotomy with marsupialization in people with Fistula in Ano, 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 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: finished, as of the sponsor's last update on 21 Dec 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 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?
Comparison of healing time in fistula in ano with and without marsupialization (time frame: 1year). 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 Dec 2022.