NCT03918213

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-25
• Primary completion: 2023-04-25
• Completion: 2024-04-25
• First posted: 2019-04-17
• Last updated: 2022-02-03

Locations

2 sites across 1 country: Russia

Regulatory

• FDA-regulated device study