Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897296
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
State Scientific Centre of Coloproctology, Russian Federation
Federal Research Centre of Nutrition and Biotechnology
Information provided by (Responsible Party):
Vasily Isakov, Russian Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Diagnostic Test: High resolution anorectal manometry, water perfused catheter Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
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 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)
Masking: None (Open Label)
Masking Description: No masking is possible
Primary Purpose: Other
Official Title: Study of Normative Metrics of High-resolution Anorectal Manometry With the Use of Water-perfused Catheter in a Russian Population Without Signs of Functional and Organic Anorectal Disorders
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: healthy subjects examined with water-perfused catheter
healthy subjects - subjects without signs of functional and organic anorectal pathology
Diagnostic Test: 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




Primary Outcome Measures :
  1. Resting anorectal pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 1 minute ]
    Anorectal pressure at rest, mm Hg

  2. Maximal squeeze pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 5 seconds ]
    Maximal pressure when a squeeze test is performed, mm Hg

  3. Maximal pressure of endurance squeeze test performed with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 30 seconds ]
    mean pressure during test, mm Hg

  4. Push test pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 5 seconds ]
    mean pressure during push test, mm Hg

  5. Cough test [ Time Frame: 5 seconds ]
    Cough test pressure, maximal

  6. Pressure of the first sensation obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 1 minute ]
    Pressure of the first sensation by the test of reservoir function of the rectum, mm Hg

  7. Pressure of the urge to defecate obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 1 minute ]
    Pressure of the urge to defecate by the test of reservoir function of the rectum, mm Hg

  8. Maximal tolerate volume pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 1 minute ]
    Maximal tolerate volume pressure by the test of reservoir function of the rectum, ml

  9. First pain sensation pressure obtained with the use of water-perfused catheter for high-resolution anorectal manometry [ Time Frame: 1 minute ]
    Appearance of pain sensation by the test of reservoir function of the rectum, mm Hg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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.
  5. Identification of the conditions described in the section "exclusion criteria" during examination of the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897296


Contacts
Layout table for location contacts
Contact: Sergey Morozov, MD, PhD +74996131091 morosoffsv@mail.ru
Contact: Oksana Fomenko, MD, PhD +74991990676 oksana671@yandex.ru

Locations
Layout table for location information
Russian Federation
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology Recruiting
Moscow, Russian Federation, 115446
Contact: Sergey Morozov, MD, PhD    +74996131091    84996131091@mail.ru   
State Scientific Center of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Contact: Oksana Fomenko, MD, PhD    +74991990676    oksana671@yandex.ru   
Sponsors and Collaborators
Russian Academy of Medical Sciences
State Scientific Centre of Coloproctology, Russian Federation
Federal Research Centre of Nutrition and Biotechnology

Layout table for additonal information
Responsible Party: Vasily Isakov, Professor, MD, PhD, AGAF, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03897296     History of Changes
Other Study ID Numbers: HRAM-HV
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Depersonalized individual data may be shared upon the study completion
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 5 years
Access Criteria: by request

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Vasily Isakov, Russian Academy of Medical Sciences:
high-resolution anorectal manometry
healthy
Russian population
Additional relevant MeSH terms:
Layout table for MeSH terms
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents