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

Anal Fistula Clinical Trial

Official title:

A Prospective Comparative Study to Improve Preoperative Ultrasound Diagnosis of Rectal Fistulas in the Formation of Topical Diagnosis Using B-mode and Three-dimensional Image Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03743701
• Other study ID #: 82
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: November 2018
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Larisa Orlova, Proff.
• Phone: +74991996686
• Email: lporlova2013[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• ?atients with post-traumatic fistulas

• ?atients with fistulas, drain pararectal cysts

• ?atients with anal fissures, complicated by rectal fistula

• ?atients who refused to participate in the study of their own free will

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Diagnostic Test:
• The method of transrectal ultrasound in ?-mode
A linear transrectal ultrasonic sensor with a frequency of 9 MHz is inserted into the rectum lumen to a depth of 10 cm from the edge of the anus. In real time, the rectal wall and anatomical structures of the anal canal are evaluated using linear sections. The localization of the internal fistula opening, the course of the fistula relative to the fibers of the external sphincter and the presence or absence of cellular and wall plug is determined.
• The method of transrectal ultrasound examination using three-dimensional image reconstruction.
A mechanical circular transrectal ultrasonic sensor with a frequency of 13 MHz is inserted into the rectum lumen to a depth of 10 cm from the edge of the anus. Within 30 seconds with a scan interval of 2 mm with a length of 10 cm, a circular recording of the anatomical structures of the rectum, surrounding tissue and anal canal takes place, obtaining an array of images in the form of a cube. The study was completed. After, at a convenient time for the researcher is working with a three-dimensional array of images. The resulting cube can be rotated 360 degrees in a circle of its axis, work with the sagittal, frontal and axial plane. To obtain a more visual representation of the exact localization of the internal fistula orifice, the course of the fistula relative to the fibers of the outer sphincter and to design volumetric cellular and wall plug.

Locations

Country	Name	City	State
Russian Federation	State Sceintific Centtre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity in the diagnosis of cryptogenic fistulas of the rectum	14 days