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Completed

NCT Number: NCT05223309

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Low type fistula in ano below 16 years old

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Treatment and study plan

Usinf thick loose sutures in seton techingues

Other

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.

Primary outcomes

  1. Rapid healing and less recurrent

    Time frame: 2 year

    usage of loose Seton in high type FIA

Sponsors and collaborators

Lead sponsor

Jabir Ibn Hayyan Medical University

Other

Registry information

Official study title

Loose Thick Seton Suture Stimulate Rapid Healing and Lower Recurrence Rate in the Treatment of High Type Fistula in Ano

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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