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

Not Applicable

• Conditions: Anal Fistula
• Interventions: Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction.; Diagnostic Test: The method of transrectal ultrasound in В-mode

• Registration Number: NCT03743701
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-12-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-15
• Last Update Submitted: 2018-11-15
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transrectal ultrasound examination using three-di	The method of transrectal ultrasound examination using three-dimensional image reconstruction.	-
Transrectal ultrasound in В-mode	The method of transrectal ultrasound in В-mode	-

Primary Outcome Measures

Name	Time	Method
Sensitivity	14 days	Sensitivity in the diagnosis of cryptogenic fistulas of the rectum

Trial Locations

Locations (1)

State Sceintific Centtre of Coloproctology; 🇷🇺 Moscow, Russian Federation