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

NCT05223309 | Completed DMC

• 1 other identifier: Seton
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fistula in Ano

Keywords

High type; Seton; Loose thick sutures; Recurrance

Outcome Measures

Primary Outcomes (1)

• Rapid healing and less recurrent

  usage of loose Seton in high type FIA

  2 year

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Low type fistula in ano below 16 years old

Sponsors & Collaborators

• Jabir Ibn Hayyan Medical University: lead

Study Sites (1)

Samer Al-Hakkak

Najaf, An Najaf, 00964, Iraq

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Samer Al-Hakkak, Ph.D.

  Jabir Ibn Hayyan Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: February 3, 2022
• Study Start: February 20, 2018
• Primary Completion: March 12, 2019
• Study Completion: January 25, 2021
• Last Updated: February 3, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: about 2 year
• Access Criteria: document

Locations

IR (1)