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

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ClinicalTrials.gov Identifier: NCT03743701
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
State Scientific Centre of Coloproctology, Russian Federation

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas Ultrasound

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.




Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 14 days ]
    Sensitivity in the diagnosis of cryptogenic fistulas of the rectum



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years and older
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743701


Contacts
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Contact: Larisa Orlova, Proff. +74991996686 lporlova2013@yandex.ru

Locations
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Russian Federation
State Sceintific Centtre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
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Responsible Party: State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03743701    
Other Study ID Numbers: 82
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases