Treatment of Hemorrhoid With 1940nm Laser Procedure

Not Applicable

• Conditions: Hemorrhoids
• Interventions: Procedure: sclerotherapy; Procedure: laser procedure

• Registration Number: NCT05228054
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2022-01-26
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08
• Primary Completion: 2023-12-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

hemorrhoids 2-3st

Exclusion Criteria

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sclerotherapy	sclerotherapy	Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy
Laser 1940nm	laser procedure	Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm

Primary Outcome Measures

Name	Time	Method
Reccurence rate	12 months	reccurence of hemorroids desease

Secondary Outcome Measures

Name	Time	Method
Pain intensity	7 days	Score representing patient's current pain intensity; Minimum: 0 (no pain) Maximum: 100 (very severe pain)
QoL	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

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation