NCT03743701

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2017-12-30
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2018-11-16
• Last updated: 2018-11-16

Locations

1 site across 1 country: Russia