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.
1 other identifier
interventional
150
1 country
1
Brief Summary
Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2017
CompletedFirst Submitted
Initial submission to the registry
November 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedNovember 16, 2018
November 1, 2018
2.7 years
November 8, 2018
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
14 days
Study Arms (2)
Transrectal ultrasound in В-mode
ACTIVE COMPARATORTransrectal ultrasound examination using three-di
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with "fistula of the rectum"
- Patients diagnosed with cryptogenic fistulas
- Patients who have signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Sceintific Centtre of Coloproctology
Moscow, 123423, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2018
First Posted
November 16, 2018
Study Start
December 30, 2017
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
November 16, 2018
Record last verified: 2018-11