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

Hemorrhoids Clinical Trial

— EQUALISER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743311
• Other study ID #: IC4 -05682-058-RUS
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 5, 2019

Study information

• Verified date: March 2021
• Source: Servier Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Pirogov National Surgery Center	Moscow	Pervomaisrfya 70

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Quality of Life of Patients Suffering From Acute or Chronic Hemorrhoids Within 1 Month After Presenting to a Doctor (Visit V0 vs Visit3)	The Short Form (36) Health Survey (SF36 ) scale questioner was used. SF36 is is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	1 month after presenting to a doctor
Primary	Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients	QoL assessment using the SF36 scale questioner ( assessment of QoL quastions) - added to the Referance The Short Form (36) Health Survey (SF36 ) scale questioner was used. SF36 is is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	1 month after presenting to a doctor