An interventional study of laser procedure and sclerotherapy in Hemorrhoids, sponsored by State Scientific Centre of Coloproctology, Russian Federation. Status unknown at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by State Scientific Centre of Coloproctology, Russian Federation · Not applicable, Interventional, and Treatment
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →State Scientific Centre of Coloproctology, Russian Federation is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
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hemorrhoids 2-3st
Exclusion Criteria:
Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions
Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm
Procedure: laser procedure
Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy
Procedure: sclerotherapy
In modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen
In modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol
Reccurence rate
reccurence of hemorroids desease
Time frame: 12 months
Pain intensity
Score representing patient's current pain intensity Minimum: 0 (no pain) Maximum: 100 (very severe pain)
Time frame: 7 days
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
Time frame: 12 months
Started Jan 2021 (actual). Primary completion is estimated for Dec 2023, 35 months after the start.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 35 months is above that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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State Scientific Centre of Coloproctology, Russian Federation