Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03743701|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anal Fistula||Diagnostic Test: The method of transrectal ultrasound in В-mode Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||December 30, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2020|
|Active Comparator: Transrectal ultrasound in В-mode||
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.
|Experimental: Transrectal ultrasound examination using three-di||
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.
- Sensitivity [ Time Frame: 14 days ]Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743701
|Contact: Larisa Orlova, Proff.||+email@example.com|
|State Sceintific Centtre of Coloproctology||Recruiting|
|Moscow, Russian Federation, 123423|