Clinical trial NCT03918213: Normative Metrics of High-Resolution Anorectal Manometry With the Use of Solid-State Catheter in a Healthy Russian Cohort
Official title: Normative Metrics of High-Resolution Anorectal Manometry With the Use of Solid-State Catheter in a Healthy Russian Cohort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Keywords: high-resolution anorectal manometry
solid-state catheter
healthy population
Russian population
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: State Scientific Centre of Coloproctology, Russian Federation
name: Federal Research Centre of Nutrition and Biotechnology
First posted: 2019-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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 solid-state catheter). This diagnostic procedure is not intended as one for routine examination, therefore the study type is "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 purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resting anorectal pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 1 min
measure: Maximal squeeze pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 5 sec
measure: Maximal pressure of endurance squeeze test performed with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 30 seconds
measure: Push test pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 5 seconds
measure: Cough test
timeFrame: 5 seconds
measure: Pressure of the first sensation obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 1 minute
measure: Pressure of the urge to defecate obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 1 minute
measure: Maximal tolerate volume pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 1 minute
measure: First pain sensation pressure obtained with the use of solid-state catheter for high-resolution anorectal manometry
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
city: Moscow
country: Russian Federation
facility: State Scientific Center of Coloproctology
Study officials:
affiliation: Fedreral Research Center of Nutrition and Biotechnology
name: Sergey Morozov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Scientific Center of Coloproctology
name: Oksana Fomenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: