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Randomized Trial :Hemorrhoidal Pedicle Ligation vs Laser vs Open Hemorrhoidectomy

NCT03757728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2018-11-29

No results posted yet for this study

Summary

The aim of this study is to compare three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and haemorrhoidal pedicle ligation.

To assess early outcomes (after one week and one month) of the procedures: pain, bleeding, wound healing, return to work and quality of life; To assess late outcomes (after one year) of the procedures: late functional results (continence) and recurrence of symptoms and haemorrhoids.

Study design This is a multi-center, double-blind, prospective RCT comparing three different modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.

Conditions

  • Hemorrhoids Second Degree
  • Hemorrhoids Third Degree

Interventions

PROCEDURE

Haemorrhoidectomy operations

for treatment of symptomatic 2 to 3 degree haemorrhoids

Sponsors & Collaborators

  • Biolitec Pharma Ltd.

    collaborator INDUSTRY

  • Vilnius University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-04-30
Completion
2018-11-30

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757728 on ClinicalTrials.gov