NCT03743311

Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease

The Russian Multicenter Observational Program Obtaining of Data on the Impact of Different Treatment Modalities on the Quality of Life of the Patients With Acute and Chronic Hemorrhoid Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,032 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The program is aimed at obtaining data on the impact of the method and type of treatment on the quality of life of patients with acute or chronic hemorrhoids with option of conservative treatment with Detralex

Detailed description

Changes in the quality of life of patients suffering from acute or chronic hemorrhoids within 1 month after presenting to a doctor, in general population and in specific demographic and clinical groups. The program included patients who presented to a doctor for acute or chronic hemorrhoids. All the treatment was fully compliant with the conventional clinical practice, instructions for medical use of drugs and a specific clinical situation. The standard parameters usually evaluated in patients with hemorrhoids were studied during the program. In addition, at the first visit to the doctor and at the end of the study, the patient filled out an SF-36 questionnaire for assessing the QoL The general population of patients included in the program, the following three groups of patients were considered: * Group 1, with only conservative (medical) therapy during the study; * Group 2, with conservative (medical) therapy and additional minimally invasive procedure during the study (no surgery); * Group 3, with conservative (medical) therapy and additional surgery for hemorrhoids during the study.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
PROCEDURE	Hemorrhoidectomy, Thrombectomy , Operation on Longo method	Surgical procedures for treatment of Hemorhoid
DRUG	Detralex	Conservative treatment of Hemorhoid
OTHER	Combined therapy	Surgical + conservative treatment of Hemorhoid

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-06-05
• Completion: 2019-06-05
• First posted: 2018-11-16
• Last updated: 2021-03-29
• Results posted: 2021-03-29

Locations

1 site across 1 country: Russia