Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.

State Scientific Centre of Coloproctology, Russian Federation

Status: Unknown

Conditions: Anal Fistula

Treatments: Diagnostic Test: The method of transrectal ultrasound in В-mode; Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction.

Study type: Interventional

Funder types: Other

Identifiers

NCT03743701

82

Details and patient eligibility

About

Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum

Full description

It is planned to investigate 150 patients with cryptogenic fistulas. Patients will be divided into two groups: complete and incomplete internal fistulas of the rectum. Patients of the first group will undergo preoperative examination in the framework of transrectal ultrasound in B-mode, three-dimensional reconstruction of the image with a contrast of the fistula course with a solution of 1.5% hydrogen peroxide. Patients with incomplete internal fistulas of the rectum will also undergo transrectal ultrasound examination in B-mode and with three-dimensional image reconstruction. The results obtained in the two groups will be compared with the intraoperative revision.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients diagnosed with "fistula of the rectum"
• Patients diagnosed with cryptogenic fistulas
• Patients who have signed informed consent

Exclusion criteria

• Patients with perianal complications of Crohn's disease
• Рatients with post-traumatic fistulas
• Рatients with fistulas, drain pararectal cysts
• Рatients with anal fissures, complicated by rectal fistula
• Рatients who refused to participate in the study of their own free will

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Transrectal ultrasound in В-mode

Active Comparator group

Treatment:

Diagnostic Test: The method of transrectal ultrasound in В-mode

Transrectal ultrasound examination using three-di

Experimental group

Treatment:

Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction.