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NCT Number: NCT03743311

Data on the Impact of Different Treatment on the Quality of Life of 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

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pirogov National Surgery Center

Moscow, Pervomaisrfya 70, 105203, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years;
  • Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,
  • Absence of conditions requiring urgent medical care and not related to hemorrhoids;
  • The patient was diagnosed with:
  • Acute hemorrhoids;
  • Exacerbation of chronic hemorrhoids;
  • Chronic hemorrhoids

Exclusion criteria

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

Treatment and study plan

Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Procedure

Surgical procedures for treatment of Hemorhoid

Detralex

Drug

Conservative treatment of Hemorhoid

Combined therapy

Other

Surgical + conservative treatment of Hemorhoid

Primary outcomes

  1. 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)

    Time frame: 1 month after presenting to a doctor

    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.

  2. Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients

    Time frame: 1 month after presenting to a doctor

    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.

Sponsors and collaborators

Lead sponsor

Servier Russia

Industry

Registry information

Official study 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

Acronym: EQUALISER

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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