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

NCT ID: NCT05223309

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2021-01-25

Brief Summary

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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

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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

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Fistula in Ano

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Usinf 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.

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jabir Ibn Hayyan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samer Al-Hakkak, Ph.D.

Role: STUDY_CHAIR

Jabir Ibn Hayyan Medical University

Locations

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Samer Al-Hakkak

Najaf, An Najaf, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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Seton

Identifier Type: -

Identifier Source: org_study_id

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