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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-06-05

Brief Summary

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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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Detailed Description

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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

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Hemorrhoids

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical treatment of Hemmorhoid

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

Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Intervention Type PROCEDURE

Surgical procedures for treatment of Hemorhoid

Conservative treatment of Hemmorhoid

Patients taken conservative treatment (Detralex)

Detralex

Intervention Type DRUG

Conservative treatment of Hemorhoid

Combined treatment of Hemmorhoid

Combined treatment patients (surgery and conservative treatment)

Combined therapy

Intervention Type OTHER

Surgical + conservative treatment of Hemorhoid

Interventions

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Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Surgical procedures for treatment of Hemorhoid

Intervention Type PROCEDURE

Detralex

Conservative treatment of Hemorhoid

Intervention Type DRUG

Combined therapy

Surgical + conservative treatment of Hemorhoid

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No