Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
The method of transrectal ultrasound in В-mode
The method of transrectal ultrasound examination using three-dimensional image reconstruction.
Sponsored by
About this trial
This is an interventional diagnostic trial for Anal Fistula
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
Sites / Locations
- State Sceintific Centtre of ColoproctologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Transrectal ultrasound in В-mode
Transrectal ultrasound examination using three-di
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
Secondary Outcome Measures
Full Information
NCT ID
NCT03743701
First Posted
November 8, 2018
Last Updated
November 15, 2018
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT03743701
Brief Title
Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transrectal ultrasound in В-mode
Arm Type
Active Comparator
Arm Title
Transrectal ultrasound examination using three-di
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
The method of transrectal ultrasound in В-mode
Intervention Description
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
Intervention Name(s)
The method of transrectal ultrasound examination using three-dimensional image reconstruction.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
Time Frame
14 days
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18 years and older
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Larisa Orlova, Proff.
Phone
+74991996686
Email
lporlova2013@yandex.ru
Facility Information:
Facility Name
State Sceintific Centtre of Coloproctology
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
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