Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Mansoura University

Status: Completed

Conditions: Anal Fistula

Treatments: Procedure: Marsupialization; Procedure: Fistulotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03595839

mansoura60

Details and patient eligibility

About

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both genders
• Age: 18-65 years
• All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion criteria

• High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
• Recurrent anal fistulas.
• Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
• High risk patients according to ASA (American society of anesthesiologists )
• Any degree of incontinence.
• Patients with previous anal surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Fistulotomy with Marsupialization

Active Comparator group

Description:

Lay open and Marsupialization of the fistula track

Treatment:

Procedure: Fistulotomy

Procedure: Marsupialization

Fistulotomy without Marsupialization

Active Comparator group

Description:

lay open of the fistula track

Treatment:

Procedure: Fistulotomy