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

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

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

Study Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method; Drug: Detralex; Other: Combined therapy

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.

• Study Type: Observational
• Enrollment (Actual): 1032

Contacts and Locations

Study Locations

• Russian Federation
  • Pervomaisrfya 70
    • Moscow, Pervomaisrfya 70, Russian Federation, 105203
      • Pirogov National Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic hemorrhoids.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical treatment of Hemmorhoid; Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)	Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method; Surgical procedures for treatment of Hemorhoid
Conservative treatment of Hemmorhoid; Patients taken conservative treatment (Detralex)	Drug: Detralex; Conservative treatment of Hemorhoid
Combined treatment of Hemmorhoid; Combined treatment patients (surgery and conservative treatment)	Other: Combined therapy; Surgical + conservative treatment of Hemorhoid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Servier Russia
• Investigators: Study Chair: Olga LINNIK

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: IC4 -05682-058-RUS

Plan for Individual participant data (IPD)

Study Data/Documents

1. the SF36 scale questioner
   Information comments: The scale the SF36 scale questioner can be sent by email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No