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.

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

Study Overview

• Status: Unknown
• Conditions: Anal Fistula
• Intervention / Treatment: Diagnostic test: The method of transrectal ultrasound in В-mode; Diagnostic test: The method of transrectal ultrasound examination using three-dimensional image reconstruction.

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larisa Orlova, Proff.; Phone Number: +74991996686; Email: lporlova2013@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123423
    • Recruiting
    • State Sceintific Centtre of Coloproctology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity in the diagnosis of cryptogenic fistulas of the rectum	14 days

Collaborators and Investigators

• Sponsor: State Scientific Centre of Coloproctology, Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 82

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No