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

NCT ID: NCT03743701

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2020-08-31

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.

Conditions

Anal Fistula

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transrectal ultrasound in В-mode

Group Type: ACTIVE_COMPARATOR

The method of transrectal ultrasound in В-mode

Intervention Type: DIAGNOSTIC_TEST

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.

Transrectal ultrasound examination using three-di

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

The method of transrectal ultrasound in В-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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State Sceintific Centtre of Coloproctology

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Larisa Orlova, Proff.

Role: CONTACT

lporlova2013@yandex.ru

+74991996686

Other Identifiers

82

Identifier Type: -

Identifier Source: org_study_id