NCT05228054

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

January 26, 2022

Last Update Submit

February 7, 2022

Conditions

Hemorrhoids

Keywords

hemorrhoids, laser, sclerotherapy

Outcome Measures

Primary Outcomes (1)

  • Reccurence rate

    reccurence of hemorroids desease

    12 months

Secondary Outcomes (2)

  • Pain intensity

    7 days

  • QoL

    12 months

Study Arms (2)

Laser 1940nm

EXPERIMENTAL

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

Procedure: laser procedure

sclerotherapy

ACTIVE COMPARATOR

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

Procedure: sclerotherapy

Interventions

laser procedurePROCEDURE

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

Laser 1940nm
sclerotherapyPROCEDURE

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

sclerotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemorrhoids 2-3st

You may not qualify if:

  • Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Scientific Centre of Coloproctology

Moscow, 123423, Russia

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Interventions

Sclerotherapy

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with hemorrhoids 2-3st will be randomized in two groups
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 8, 2022

Study Start

January 26, 2021

Primary Completion

December 30, 2023

Study Completion

August 30, 2024

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

RU(1)