Normative Metrics of High-Resolution Anorectal Manometry With the Use of Water-perfused System in a Healthy Russian Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2024-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Normative Metrics of High-Resolution Anorectal Manometry With the Use of Solid-State Catheter in a Healthy Russian Cohort

NCT03918213

Healthy Subjects

UNKNOWN NA

Normal Values in Ano-rectal 3D High Resolution Manometry

NCT01710579

Anorectal Disorder Fecal Incontinence Constipation

COMPLETED NA

Does Body Position Influence Pressure Recording by High-resolution Manometry ?

NCT01946334

Anal Incontinence or Constipation

COMPLETED NA

Quality of Life After Transanal Endoscopic Microsurgery (TEM)

NCT03675243

Transanal Endoscopic Microsurgery (TEM)

COMPLETED

Anorectal Manometery in Pediatric Chronic Refractory Constipation

NCT06543979

Chronic Constipation

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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)

Primary Study Purpose

OTHER

Blinding Strategy

NONE

No masking is possible

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy subjects examined with water-perfused catheter

healthy subjects - subjects without signs of functional and organic anorectal pathology

Group Type EXPERIMENTAL

High resolution anorectal manometry, water perfused catheter

Intervention Type DIAGNOSTIC_TEST

High resolution anorectal manometry with the use of water-perfused catheter will be performed to eligible subjects willing to participate in the study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High resolution anorectal manometry, water perfused catheter

High resolution anorectal manometry with the use of water-perfused catheter will be performed to eligible subjects willing to participate in the study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* 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:

1. 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.
2. Incomplete high-resolution anorectal manometry procedure.
3. Presence of adverse event(s) during high-resolution anorectal manometry procedure, causing the further procedure impossible.
4. Obtaining incomplete recording of high-resolution anorectal manometry parameters for any reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes