Treatment of Hemorrhoid With 1940nm Laser Procedure

February 7, 2022 updated by: State Scientific Centre of Coloproctology, Russian Federation
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.

Follow up for one year. Primary end point - recurrence of hemorrhoids desease.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 123423
        • Recruiting
        • State Scientific Centre of Coloproctology
        • Contact:
          • Sergey Achkasov, MD
          • Phone Number: +7-495-199-6783
          • Email: info@gnck.ru
        • Sub-Investigator:
          • Vyacheslav Korolik, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

hemorrhoids 2-3st

Exclusion Criteria:

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser 1940nm
Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm
Procedure: laser procedure
In modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen
Active Comparator: sclerotherapy
Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy
Procedure: sclerotherapy
In modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reccurence rate
Time Frame: 12 months
reccurence of hemorroids desease
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 7 days

Score representing patient's current pain intensity

Minimum: 0 (no pain) Maximum: 100 (very severe pain)
7 days
QoL
Time Frame: 12 months
The SF-36 is often used as a measure of a person or population's quality of life (QOL) The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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