Perianal FistulaNCT03763981
Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
A study testing prolene seton treatment and silk seton treatment in people with Perianal Fistula, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- prolene seton treatment and silk seton treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2017to 30 Aug 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes and aged 20 years and above with high perianal fistula
Who cannot join
- Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
It is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.
- Conditions
- Perianal Fistula
- Being tested
- prolene seton treatment, silk seton treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolene seton treatmentProcedure or surgery
patients with perianal fistulas will treated with seton placement by prolene thread
silk seton treatmentProcedure or surgery
patients with perianal fistulas will treated with seton placement by silk thread
| Study group | Role | What they receive |
|---|---|---|
| prolene seton | Active comparator | Prolene thread will be used as seton treatment for perianal fistulas Receives: Procedure: prolene seton treatment |
| silk seton | Active comparator | Silk thread will be used as seton treatment for perianal fistulas Receives: Procedure: silk seton treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula healing
fistula healing, complete healing of wound with no external opening of fistula
Measured: 8 to 12 weeks
Secondary outcomes (1)
Fistula recurrence
Recurrence of perianal fistula after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Sep 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763981
- Sponsor's protocol ID
- s5
- Status last verified
- Dec 2018
- First submitted
- 10 Jul 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula
- ClinicalTrials.gov ID
- NCT03763981
- Acronym / sponsor ID
- s5
- Conditions
- Perianal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 4 Dec 2018 (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 is a randomized control trial in which we will treat the patients with perianal fistula with seton placement. We will divide the patients in two groups. Group I will be treated with silk seton and Group II will be treated with prolene setone. The outcome will be then followed as fistula healing and recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolene seton | Active comparator | Procedure: prolene seton treatmentProlene thread will be used as seton treatment for perianal fistulas |
| silk seton | Active comparator | Procedure: silk seton treatmentSilk thread will be used as seton treatment for perianal fistulas |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes and aged 20 years and above with high perianal fistula
Key exclusion criteria (1 listed)
- Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma
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 |
|---|---|---|
| prolene seton treatmentpatients with perianal fistulas will treated with seton placement by prolene thread | Procedure or surgery | prolene seton |
| silk seton treatmentpatients with perianal fistulas will treated with seton placement by silk thread | Procedure or surgery | silk seton |
Primary outcome
fistula healing
Time frame: 8 to 12 weeks
fistula healing, complete healing of wound with no external opening of fistula
1 secondary outcome
Fistula recurrence
Time frame: 6 months
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 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prolene seton treatment and silk seton treatment in people with Perianal Fistula, run by Services Hospital, Lahore 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 4 Dec 2018. 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?
fistula healing (time frame: 8 to 12 weeks). 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 4 Dec 2018.