Healthy SubjectsNCT03897296
Normative Metrics of High-Resolution Anorectal Manometry With the Use of Water-perfused System in a Healthy Russian Cohort
A study testing High resolution anorectal manometry, water perfused catheter in people with Healthy Subjects, run by Russian Academy of Medical Sciences at 2 sites in Russia.
Trial summary
High resolution anorectal manometry (HRAM) normative values are still need to be studied in different populations and with the use of different (solid-state and water-perfused) systems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- High resolution anorectal manometry, water perfused catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesRussia
- Study dates
- 15 Apr 2019to 15 Apr 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate in this clinical trial, confirmed by signed informed consent form.
- Patients of both sexes, aged 18 to 65 years inclusive.
- Permanent residence in the Russian Federation (capable citizens of Russia on the basis of a passport of a citizen of the Russian Federation).
- Absence of rectal diseases, confirmed by the results of clinical and instrumental examinations
- Ability to follow the instructions when high-resolution anorectal manometry procedure is performed.
Who cannot join
- Known diseases of the rectum on the basis of clinical and / or instrumental examination, including presence of complaints to difficulties with defecations that require manual aids or use of laxatives;
- Surgical interventions on pelvic organs in history;
- History of organ transplantation except for corneal transplantation and eye lens replacement surgery;
- Oncology of any localization, with the exception of skin cancer in situ;
- Severe concomitant pathology of any organs and systems, which, in the opinion of the researcher, makes it impossible to carry out the procedure of high-resolution anorectal manometry or if the procedure may cause the risk of worsen the patient's condition;
- Absence of anamnestic, clinical and laboratory signs of alcohol abuse (abuse will be considered in case of the use of more than 30 g of pure alcohol per day by males and the use of more than 20 g of pure alcohol per day by females;
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- Use of illegal drugs, including history;
- Use of concomitant medications that can affect the motor function of the colon (including, but not limited to: calcium channel blockers, metoclopramide, m-cholinolytics, domperidone, nitrates, tricyclic antidepressants, opiates, beta-blockers, beta-adrenomimetics, alcohol). The duration of the period of non-use of these drugs should provide sufficient time for the complete cessation of their pharmacological action, but not less than two half-life periods.
- Pregnancy and breast-feeding;
- Technical impossibility to insert the catheter due to the previously known or current poor tolerability of high-resolution anorectal manometry procedure or due to the presence of anatomical features that make it impossible to insert the catheter.
- Criteria of non-inclusion of the data to the analysis:
- Patients may choose to stop their participation in the study by withdrawal of their previously signed consent, that leads to the exclusion of their data from the analysis.
- The researcher should be guided by the following criteria, however, he may at any time terminate the patient's participation in the study on the basis of his own clinical judgment.
- Cancellation of participation in the study can be carried out on the basis of the following events:
- Lack of the possibility to insert water-perfused catheter during high-resolution anorectal manometry procedure due to anatomical features or psychological state of the patient.
- Incomplete high-resolution anorectal manometry procedure.
- Presence of adverse event(s) during high-resolution anorectal manometry procedure, causing the further procedure impossible.
- Obtaining incomplete recording of high-resolution anorectal manometry parameters for any reason.
- Identification of the conditions described in the section "exclusion criteria" during examination of the patient.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, 115446
Sergey Morozov, MD, PhD, +74996131091, 84996131091@mail.ru
- Recruiting
State Scientific Center of Coloproctology
Moscow, 123423
Oksana Fomenko, MD, PhD, +74991990676, oksana671@yandex.ru
About this study
Official title: Study of Normative Metrics of High-resolution Anorectal Manometry With the Use of Water-perfused Catheter in a Russian Population Without Signs of Functional and Organic Anorectal Disorders
High resolution anorectal manometry (HRAM) normative values are still need to be studied in different populations and with the use of different (solid-state and water-perfused) systems. No studies on HRAM normative values in a Russian population without signs of functional and organic anorectal pathology has been carried out yet.
Read the detailed description
High-resolution anorectal manometry (HRAM) is a modern technique used to evaluate the function of the rectum and its sphincters. It is intended to measure the resting pressure in the anal canal, as well as pressure during voluntary contraction of the external anorectal sphincter and pelvic floor muscles and to evaluate reactions to the functional tests.
Several studies have been performed to evaluate normative metrics of anorectal manometry to the moment, but most of them enrolled patients living in the US and countries of the Western Europe. Nutritional patterns, ethnic composition of the population and other factors may cause the differences in the mormative values of HRAM in different populations. Current study is organized to evaluate normative metrics of HRAM in a Russian healthy cohort.
- Conditions
- Healthy Subjects
- Being tested
- High resolution anorectal manometry, water perfused catheter
- Keywords
- high-resolution anorectal manometry, healthy, Russian population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution anorectal manometry, water perfused catheterDiagnostic test
High resolution anorectal manometry with the use of water-perfused catheter will be performed to eligible subjects willing to participate in the study
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects examined with water-perfused catheter | Experimental | healthy subjects - subjects without signs of functional and organic anorectal pathology Receives: Diagnostic Test: High resolution anorectal manometry, water perfused catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting anorectal pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Anorectal pressure at rest, mm Hg
Measured: 1 minute
Maximal squeeze pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Maximal pressure when a squeeze test is performed, mm Hg
Measured: 5 seconds
Maximal pressure of endurance squeeze test performed with the use of water-perfused catheter for high-resolution anorectal manometry
mean pressure during test, mm Hg
Measured: 30 seconds
Push test pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
mean pressure during push test, mm Hg
Measured: 5 seconds
Cough test
Cough test pressure, maximal
Measured: 5 seconds
Pressure of the first sensation obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Pressure of the first sensation by the test of reservoir function of the rectum, mm Hg
Measured: 1 minute
Pressure of the urge to defecate obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Pressure of the urge to defecate by the test of reservoir function of the rectum, mm Hg
Measured: 1 minute
Maximal tolerate volume pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Maximal tolerate volume pressure by the test of reservoir function of the rectum, ml
Measured: 1 minute
First pain sensation pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Appearance of pain sensation by the test of reservoir function of the rectum, mm Hg
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start15 Apr 2019
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Normative values for the routine procedure of high-resolution anorectal manometry for Russian population has not been studied yet. Some factors allows to suggest that normative values may differ from those obtained in other countries. This pilot study is aimed to either support the null-hypothesis of the presence of the differences or decline it. It is expected to obtain primary data that could be used for further work and planning of the cohort studies. During the study, healthy volunteers are to be examined with a registered diagnostic tool (i.e. high-resolution anorectal manometry with water-perfused catheter). This diagnostic procedure is not intended as one for routine examination, therefore the study type is changed to the "interventional", though no pharmacological intervention or surgery is planned. The estimated sample size sufficient to reach the power of 80%, and type 1 error 0.05 was obtained with single-sample t-test of Statistica10 (StatSoft, USA)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- State Scientific Centre of Coloproctology, Russian Federation, Federal State Budgetary Scientific Institution
- Responsible party
- Principal investigator, Vasily Isakov, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897296
- Sponsor's protocol ID
- HRAM-HV
- Status last verified
- Feb 2022
- First submitted
- 26 Mar 2019
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Depersonalized individual data may be shared upon the study completion
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Normative Metrics of High-resolution Anorectal Manometry With the Use of Water-perfused Catheter in a Russian Population Without Signs of Functional and Organic Anorectal Disorders
- ClinicalTrials.gov ID
- NCT03897296
- Acronym / sponsor ID
- HRAM-HV
- Conditions
- Healthy Subjects
- Keywords
- high-resolution anorectal manometry, healthy, Russian population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- State Scientific Centre of Coloproctology, Russian Federation, Federal State Budgetary Scientific Institution
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 1 Apr 2019 (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.
High resolution anorectal manometry (HRAM) normative values are still need to be studied in different populations and with the use of different (solid-state and water-perfused) systems. No studies on HRAM normative values in a Russian population without signs of functional and organic anorectal pathology has been carried out yet.
Detailed description
High-resolution anorectal manometry (HRAM) is a modern technique used to evaluate the function of the rectum and its sphincters. It is intended to measure the resting pressure in the anal canal, as well as pressure during voluntary contraction of the external anorectal sphincter and pelvic floor muscles and to evaluate reactions to the functional tests.
Several studies have been performed to evaluate normative metrics of anorectal manometry to the moment, but most of them enrolled patients living in the US and countries of the Western Europe. Nutritional patterns, ethnic composition of the population and other factors may cause the differences in the mormative values of HRAM in different populations. Current study is organized to evaluate normative metrics of HRAM in a Russian healthy cohort.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Normative values for the routine procedure of high-resolution anorectal manometry for Russian population has not been studied yet. Some factors allows to suggest that normative values may differ from those obtained in other countries. This pilot study is aimed to either support the null-hypothesis of the presence of the differences or decline it. It is expected to obtain primary data that could be used for further work and planning of the cohort studies. During the study, healthy volunteers are to be examined with a registered diagnostic tool (i.e. high-resolution anorectal manometry with water-perfused catheter). This diagnostic procedure is not intended as one for routine examination, therefore the study type is changed to the "interventional", though no pharmacological intervention or surgery is planned. The estimated sample size sufficient to reach the power of 80%, and type 1 error 0.05 was obtained with single-sample t-test of Statistica10 (StatSoft, USA)
| Arm | Type | Receives |
|---|---|---|
| healthy subjects examined with water-perfused catheter | Experimental | Diagnostic Test: High resolution anorectal manometry, water perfused catheterhealthy subjects - subjects without signs of functional and organic anorectal pathology |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in this clinical trial, confirmed by signed informed consent form.
- Patients of both sexes, aged 18 to 65 years inclusive.
- Permanent residence in the Russian Federation (capable citizens of Russia on the basis of a passport of a citizen of the Russian Federation).
- Absence of rectal diseases, confirmed by the results of clinical and instrumental examinations
- Ability to follow the instructions when high-resolution anorectal manometry procedure is performed.
Key exclusion criteria (19 listed)
- Known diseases of the rectum on the basis of clinical and / or instrumental examination, including presence of complaints to difficulties with defecations that require manual aids or use of laxatives;
- Surgical interventions on pelvic organs in history;
- History of organ transplantation except for corneal transplantation and eye lens replacement surgery;
- Oncology of any localization, with the exception of skin cancer in situ;
- Severe concomitant pathology of any organs and systems, which, in the opinion of the researcher, makes it impossible to carry out the procedure of high-resolution anorectal manometry or if the procedure may cause the risk of worsen the patient's condition;
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 |
|---|---|---|
| High resolution anorectal manometry, water perfused catheterHigh resolution anorectal manometry with the use of water-perfused catheter will be performed to eligible subjects willing to participate in the study | Diagnostic test | healthy subjects examined with water-perfused catheter |
Primary outcome
Resting anorectal pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 1 minute
Anorectal pressure at rest, mm Hg
Maximal squeeze pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 5 seconds
Maximal pressure when a squeeze test is performed, mm Hg
Maximal pressure of endurance squeeze test performed with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 30 seconds
mean pressure during test, mm Hg
Push test pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 5 seconds
mean pressure during push test, mm Hg
Cough test
Time frame: 5 seconds
Cough test pressure, maximal
Pressure of the first sensation obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 1 minute
Pressure of the first sensation by the test of reservoir function of the rectum, mm Hg
Pressure of the urge to defecate obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 1 minute
Pressure of the urge to defecate by the test of reservoir function of the rectum, mm Hg
Maximal tolerate volume pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 1 minute
Maximal tolerate volume pressure by the test of reservoir function of the rectum, ml
First pain sensation pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry
Time frame: 1 minute
Appearance of pain sensation by the test of reservoir function of the rectum, mm Hg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. Depersonalized individual data may be shared upon the study completion
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution anorectal manometry, water perfused catheter in people with Healthy Subjects, run by Russian Academy of Medical Sciences at 2 sites 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 5 inclusion and 19 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sergey Morozov, MD, PhD (+74996131091, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting anorectal pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry (time frame: 1 minute). The study lists 9 primary outcomes in all. 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 3 Feb 2022.