Anal FistulaNCT03743701
Endorectal Three-dimensional Ultrasound in the Diagnosis of Cryptogenic Fistulas of the Rectum.
A study testing The method of transrectal ultrasound in В-mode and The method of transrectal ultrasound examination using three-dimensional image reconstruction. in people with Anal Fistula, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Fistula
- What is being tested?
- The method of transrectal ultrasound in В-mode and The method of transrectal ultrasound examination using three-dimensional image reconstruction.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 30 Dec 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with "fistula of the rectum"
- Patients diagnosed with cryptogenic fistulas
- Patients who have signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Sceintific Centtre of Coloproctology
Moscow, 123423
About this study
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.
Prospective comparative parallel ultrasound diagnostic transrectal study in the diagnosis of cryptogenic fistulas of the rectum
Read the 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.
- Conditions
- Anal Fistula
- Being tested
- The method of transrectal ultrasound in В-mode, The method of transrectal ultrasound examination using three-dimensional image reconstruction.
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The method of transrectal ultrasound in В-modeDiagnostic test
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.
The method of transrectal ultrasound examination using three-dimensional image reconstruction.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal ultrasound in В-mode | Active comparator | Not described Receives: Diagnostic Test: The method of transrectal ultrasound in В-mode |
| Transrectal ultrasound examination using three-di | Experimental | Not described Receives: Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start30 Dec 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743701
- Sponsor's protocol ID
- 82
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03743701
- Acronym / sponsor ID
- 82
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal ultrasound in В-mode | Active comparator | Diagnostic Test: The method of transrectal ultrasound in В-mode |
| Transrectal ultrasound examination using three-di | Experimental | Diagnostic Test: The method of transrectal ultrasound examination using three-dimensional image reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with "fistula of the rectum"
- Patients diagnosed with cryptogenic fistulas
- Patients who have signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The method of transrectal ultrasound in В-modeA 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. | Diagnostic test | Transrectal ultrasound in В-mode |
| 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. | Diagnostic test | Transrectal ultrasound examination using three-di |
Primary outcome
Sensitivity
Time frame: 14 days
Sensitivity in the diagnosis of cryptogenic fistulas of the rectum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Related trials for Anal Fistula
Active, not recruitingPhase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Anal Fistula
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The method of transrectal ultrasound in В-mode and The method of transrectal ultrasound examination using three-dimensional image reconstruction. in people with Anal Fistula, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Larisa Orlova, Proff. (+74991996686, lporlova2013@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.