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Treatment of Hemorrhoid With 1940nm Laser Procedure

Primary Purpose

Hemorrhoids

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

laser procedure

sclerotherapy

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoids, laser, sclerotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hemorrhoids 2-3st

Exclusion Criteria:

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Sites / Locations

State Scientific Centre of ColoproctologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser 1940nm

sclerotherapy

Arm Description

Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm

Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy

Outcomes

Primary Outcome Measures

Reccurence rate

reccurence of hemorroids desease

Secondary Outcome Measures

Pain intensity

Score representing patient's current pain intensity Minimum: 0 (no pain) Maximum: 100 (very severe pain)

QoL

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

Full Information

NCT ID

NCT05228054

First Posted

January 26, 2022

Last Updated

February 7, 2022

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

1. Study Identification

Unique Protocol Identification Number

NCT05228054

Brief Title

Treatment of Hemorrhoid With 1940nm Laser Procedure

Official Title

Treatment of Hemorrhoid With 1940nm Laser Procedure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids

Keywords

hemorrhoids, laser, sclerotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients with hemorrhoids 2-3st will be randomized in two groups

Masking

Investigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser 1940nm

Arm Type

Experimental

Arm Description

Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm

Arm Title

sclerotherapy

Arm Type

Active Comparator

Arm Description

Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy

Intervention Type

Procedure

Intervention Name(s)

laser procedure

Intervention Description

In modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen

Intervention Type

Procedure

Intervention Name(s)

sclerotherapy

Intervention Description

In modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol

Primary Outcome Measure Information:

Title

Reccurence rate

Description

reccurence of hemorroids desease

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Pain intensity

Description

Score representing patient's current pain intensity Minimum: 0 (no pain) Maximum: 100 (very severe pain)

Time Frame

7 days

Title

QoL

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hemorrhoids 2-3st Exclusion Criteria: Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Facility Information:

Facility Name

State Scientific Centre of Coloproctology

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sergey Achkasov, MD

Phone

+7-495-199-6783

info@gnck.ru

First Name & Middle Initial & Last Name & Degree

Vyacheslav Korolik, PhD

12. IPD Sharing Statement

Learn more about this trial

Treatment of Hemorrhoid With 1940nm Laser Procedure

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