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CompletedNCT05223309Updated Feb 3, 2022

High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures

An observational study in Fistula in Ano, sponsored by Jabir Ibn Hayyan Medical University. Completed at 1 site in Iraq. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Jabir Ibn Hayyan Medical University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Fistula in Ano

Keywords

  • High type
  • Seton
  • Loose thick sutures
  • Recurrance
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 100 is close to the median of 94 across 50 observational studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Jabir Ibn Hayyan Medical University is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Age distribution of patients showed that the highest rate of patients lies between the ages of 20-60 years adult population

Inclusion criteria

  • High type fistula in ano Recurrent high type fistula in ano Non abscess cases

Exclusion criteria

Exclusion Criteria:

Low type fistula in ano below 16 years old

-

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • OtherUsinf thick loose sutures in seton techingues

    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.

06

What researchers measure

Primary outcomes

  1. Rapid healing and less recurrent

    usage of loose Seton in high type FIA

    Time frame: 2 year

07

Study locations

1 site
  • Samer Al-Hakkak
    Najaf, An Najaf 00964, Iraq
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References and documents

Individual participant data

Plan to share: Yes — Share data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05223309
Lead sponsor
Jabir Ibn Hayyan Medical University
Responsible party
Sponsor
First posted
Feb 3, 2022
Start date
Feb 20, 2018
Primary completion
Mar 12, 2019
Completion
Jan 25, 2021
Last update
Feb 3, 2022

Study contacts

Samer Al-Hakkak, Ph.D.
study chair · Jabir Ibn Hayyan Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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