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

Servier

Status: Completed

Conditions: Hemorrhoids

Treatments: Drug: Detralex; Other: Combined therapy; Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Study type: Observational

Funder types: Industry

Identifiers

NCT03743311

IC4 -05682-058-RUS

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,032 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 18 years;

2. Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,

3. Absence of conditions requiring urgent medical care and not related to hemorrhoids;

4. The patient was diagnosed with:

   • Acute hemorrhoids;
   • Exacerbation of chronic hemorrhoids;
   • Chronic hemorrhoids

Exclusion criteria

1. The patient is consulting for an urgent issue not related to hemorrhoids;
2. The presence of severe systemic diseases;
3. Pregnancy;
4. Inability to understand the meaning of the Program and follow the doctor's recommendations
5. Patients with inflammatory bowel diseases
6. Patients with concomitant diseases of the anal canal
7. Patients taking anticoagulants;
8. Patients with previous anorectal surgeries, including hemorrhoidectomy or excision of anal fistula.

Trial design

1,032 participants in 3 patient groups

Surgical treatment of Hemmorhoid

Description:

Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)

Treatment:

Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Conservative treatment of Hemmorhoid

Description:

Patients taken conservative treatment (Detralex)

Treatment:

Drug: Detralex

Combined treatment of Hemmorhoid

Description:

Combined treatment patients (surgery and conservative treatment)

Treatment:

Other: Combined therapy