Treatment of Hemorrhoid With 1940nm Laser Procedure

Hemorrhoids Clinical Trial

Official title:

Treatment of Hemorrhoid With 1940nm Laser Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228054
• Other study ID #: 34
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2022
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

hemorrhoids 2-3st

Exclusion Criteria:

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• laser procedure
In modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen
• sclerotherapy
In modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol

Locations

Country	Name	City	State
Russian Federation	State Scientific Centre of Coloproctology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reccurence rate	reccurence of hemorroids desease	12 months
Secondary	Pain intensity	Score representing patient's current pain intensity; Minimum: 0 (no pain) Maximum: 100 (very severe pain)	7 days
Secondary	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	12 months