The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula

Assiut University

Status: Unknown

Conditions: High Anal Fistula

Treatments: Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04796376

AssiutU MNZaher

Details and patient eligibility

About

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

Full description

Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult with age of or above 18 years.
• Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
• Patients sable to comply to with the study protocol.

Exclusion criteria

• Patients with low perianal fistula
• Patients with preoperative incontinence.
• Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
• Patients diagnosed with acute anal sepsis
• Recurrent cases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Cutting seton

Other group

Description:

A piece of surgical thread that's left in the fistula for several weeks to keep it open. This allow it to drain and help its heal.

Treatment:

Procedure: combined partial fistulectomy or fistulotomy and cutting seton procedure