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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Diagnostic test: High-Resolution anorectal manometry with the use of solid-state catheter

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oksana Fomenko, MD, PhD; Phone Number: +74991990676; Email: oksana671@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Recruiting
    • Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
  • Moscow, Russian Federation, 123423
    • Recruiting
    • State Scientific Center of Coloproctology
    • Contact: Oksana Fomenko, MD, PhD; Phone Number: +74991990676; Email: oksana671@yandex.ru
    • Principal Investigator: Oksana Y Fomenko, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy subjects examined with solid-state catheter; healthy subjects - subjects without signs of functional and organic anorectal pathology	Diagnostic test: High-Resolution anorectal manometry with the use of solid-state catheter; High resolution anorectal manometry with the use of solid-state catheter will be performed to eligible subjects willing to participate in the study; Other Names: High-resolution anorectal manometry, solid-state catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting anorectal pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry	Anorectal pressure at rest, mm Hg	1 min
Maximal squeeze pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry	Maximal pressure when a squeeze test is performed, mm Hg	5 sec
Maximal pressure of endurance squeeze test performed with the use of solid-state catheter for high-resolution anorectal manometry	mean pressure during test, mm Hg	30 seconds
Push test pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry	mean pressure during push test, mm Hg	5 seconds
Cough test	Cough test pressure maximal pressure, mmHg	5 seconds
Pressure of the first sensation obtained with the use of solid-state catheter for high-resolution anorectal manometry	Pressure of the first sensation by the test of reservoir function of the rectum, mm Hg	1 minute
Pressure of the urge to defecate obtained with the use of solid-state catheter for high-resolution anorectal manometry	Pressure of the urge to defecate by the test of reservoir function of the rectum, mm Hg	1 minute
Maximal tolerate volume pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry	Maximal tolerate volume (of baloon) pressure by the test of reservoir function of the rectum, ml	1 minute
First pain sensation pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry	Appearance of pain sensation by the test of reservoir function of the rectum, mm Hg	1 minute

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Collaborators: State Scientific Centre of Coloproctology, Russian Federation; Federal Research Centre of Nutrition and Biotechnology
• Investigators: Principal Investigator: Sergey Morozov, MD, PhD, Fedreral Research Center of Nutrition and Biotechnology; Principal Investigator: Oksana Fomenko, MD, PhD, State Scientific Center of Coloproctology

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Anticipated): April 25, 2023
• Study Completion (Anticipated): April 25, 2024

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: healthy population; high-resolution anorectal manometry; solid-state catheter; Russian population
• Other Study ID Numbers: HRAM-HVSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Depersonalized individual data may be shared upon the study completion
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: by request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes