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

Fistula in Ano Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223309
• Other study ID #: Seton
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: January 25, 2021

Study information

• Verified date: May 2021
• Source: Jabir Ibn Hayyan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 25, 2021
• Est. primary completion date: March 12, 2019
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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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Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Iraq	Samer Al-Hakkak	Najaf	An Najaf

Sponsors (1)

Lead Sponsor	Collaborator
Jabir Ibn Hayyan Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid healing and less recurrent	usage of loose Seton in high type FIA	2 year