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Treatment of Hemorrhoid With 1940nm Laser Procedure

Treatment of Hemorrhoid With 1940nm Laser Procedure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05228054
Enrollment
200
Registered
2022-02-08
Start date
2021-01-26
Completion date
2024-08-30
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Keywords

hemorrhoids, laser, sclerotherapy

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.

Interventions

PROCEDURElaser procedure

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

PROCEDUREsclerotherapy

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

Sponsors

State Scientific Centre of Coloproctology, Russian Federation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

hemorrhoids 2-3st

Exclusion criteria

Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Design outcomes

Primary

MeasureTime frameDescription
Reccurence rate12 monthsreccurence of hemorroids desease

Secondary

MeasureTime frameDescription
Pain intensity7 daysScore representing patient's current pain intensity Minimum: 0 (no pain) Maximum: 100 (very severe pain)
QoL12 monthsThe 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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026