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

NCT03897296 | Unknown DMC FDA Device

• 1 other identifier: HRAM-HV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. No studies on HRAM normative values in a Russian population without signs of functional and organic anorectal pathology has been carried out yet.

Conditions

Healthy Subjects

Keywords

high-resolution anorectal manometry; healthy; Russian population

Outcome Measures

Primary Outcomes (9)

• Resting anorectal pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry

  Anorectal pressure at rest, mm Hg

  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

  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

  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

  5 seconds

• Cough test

  Cough test pressure, maximal

  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

  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

  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

  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

  1 minute

Study Arms (1)

healthy subjects examined with water-perfused catheter

EXPERIMENTAL

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

Diagnostic Test: High resolution anorectal manometry, water perfused catheter

Interventions

High resolution anorectal manometry, water perfused catheter 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

healthy subjects examined with water-perfused catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead
• State Scientific Centre of Coloproctology, Russian Federation: collaborator
• Federal Research Centre of Nutrition and Biotechnology: collaborator

Study Sites (2)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, 115446, Russia

RECRUITING

State Scientific Center of Coloproctology

Moscow, 123423, Russia

RECRUITING

Central Study Contacts

Sergey Morozov, MD, PhD

CONTACT

+74996131091; morosoffsv@mail.ru

Oksana Fomenko, MD, PhD

CONTACT

+74991990676; oksana671@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is possible
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, AGAF

Model Details: 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)

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: April 15, 2019
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2024
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years
• Access Criteria: by request

Locations

RU (2)