Fistula in AnoNCT05223309
High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures
An observational study of Fistula in Ano, run by Jabir Ibn Hayyan Medical University at 1 site in Iraq.
Trial summary
Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- Usinf thick loose sutures in seton techingues
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 20 Feb 2018to 25 Jan 2021
- How long will I take part?
- 2 Years
- 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 20 to 60 years
- All sexes
- Adult
Study population: Age distribution of patients showed that the highest rate of patients lies between the ages of 20-60 years adult population
Who may be able to join
- High type fistula in ano Recurrent high type fistula in ano Non abscess cases
Who cannot join
- Low type fistula in ano below 16 years old
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Loose Thick Seton Suture Stimulate Rapid Healing and Lower Recurrence Rate in the Treatment of High Type Fistula in Ano
Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.
Read the detailed description
Background: Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.
Patients and Methods: A retrospective study. One hundred patients with high type fistula in ano treated surgically in Al-Sader Medical city and Al-Najaf daily private clinic, Najaf city, Iraq from Feb 2018 to March 2019. Fistulography and magnetic resonance imaging have taken from all patients. After that, fistulectomy with loose, thick Seton suture placed for three months. Patients with the persistence of high fistula tract underwent a second surgery and third operation until complete healing.
- Conditions
- Fistula in Ano
- Being tested
- Usinf thick loose sutures in seton techingues
- Keywords
- High type, Seton, Loose thick sutures, Recurrance
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usinf thick loose sutures in seton techinguesOther
All patients were informed about doing fistulectomy and thick silk Seton suture placement for three months by excising the extrasphincteric part and putting the Seton suture to the intersphincteric part. Then, the second stage of operation includes the excision of the changing low type tract in which the silk Seton placed. We decrease the time of Seton placement in this study for three months to reduce the annoying symptoms of the patients. Therefore, the patient admitted to the operation theater after obtaining written consent. Most of the patients anesthetized by spinal anesthesia. In the operation theater, the patient assumed a lithotomy position
. After that, the injection of a solution, which is a mixture of methylene blue dye and hydrogen peroxide into the external opening of the fistula, was done to find the internal opening. The exit of color dye or bubbles achieved to localized of inner opening from it after using intraoperative proctoscopy examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid healing and less recurrent
usage of loose Seton in high type FIA
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start20 Feb 2018
- Primary completion12 Mar 2019
- Study completion25 Jan 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Jabir Ibn Hayyan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samer Al-Hakkak, Ph.D., Study chair, Jabir Ibn Hayyan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223309
- Sponsor's protocol ID
- Seton
- Status last verified
- May 2021
- First submitted
- 19 Oct 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loose Thick Seton Suture Stimulate Rapid Healing and Lower Recurrence Rate in the Treatment of High Type Fistula in Ano
- ClinicalTrials.gov ID
- NCT05223309
- Acronym / sponsor ID
- Seton
- Conditions
- Fistula in Ano
- Keywords
- High type, Seton, Loose thick sutures, Recurrance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jabir Ibn Hayyan Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 3 Feb 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.
Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.
Detailed description
Background: Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.
Patients and Methods: A retrospective study. One hundred patients with high type fistula in ano treated surgically in Al-Sader Medical city and Al-Najaf daily private clinic, Najaf city, Iraq from Feb 2018 to March 2019. Fistulography and magnetic resonance imaging have taken from all patients. After that, fistulectomy with loose, thick Seton suture placed for three months. Patients with the persistence of high fistula tract underwent a second surgery and third operation until complete healing.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Age distribution of patients showed that the highest rate of patients lies between the ages of 20-60 years adult population
Key inclusion criteria (1 listed)
- High type fistula in ano Recurrent high type fistula in ano Non abscess cases
Key exclusion criteria (2 listed)
- Low type fistula in ano below 16 years old
- -
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 |
|---|---|---|
| Usinf thick loose sutures in seton techinguesAll patients were informed about doing fistulectomy and thick silk Seton suture placement for three months by excising the extrasphincteric part and putting the Seton suture to the intersphincteric part. Then, the second stage of operation includes the excision of the changing low type tract in which the silk Seton placed. We decrease the time of Seton placement in this study for three months to reduce the annoying symptoms of the patients. Therefore, the patient admitted to the operation theater after obtaining written consent. Most of the patients anesthetized by spinal anesthesia. In the operation theater, the patient assumed a lithotomy position . After that, the injection of a solution, which is a mixture of methylene blue dye and hydrogen peroxide into the external opening of the fistula, was done to find the internal opening. The exit of color dye or bubbles achieved to localized of inner opening from it after using intraoperative proctoscopy examination. | Other | – |
Primary outcome
Rapid healing and less recurrent
Time frame: 2 year
usage of loose Seton in high type FIA
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 3 Feb 2022.
- Individual participant dataSharing planned: Yes. Share data
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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.
Samer Al-Hakkak, Ph.D. study chair
Jabir Ibn Hayyan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula in Ano, run by Jabir Ibn Hayyan Medical University at 1 site in Iraq.
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 2 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 3 Feb 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 Iraq. 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?
Rapid healing and less recurrent (time frame: 2 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 3 Feb 2022.