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

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method; Drug: Detralex; Other: Combined therapy

• Registration Number: NCT03743311
• Lead Sponsor: Servier Russia

Brief 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

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 Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-16
• Study Start: 2019-03-01
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Results First Submitted: 2020-12-04
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Results First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1032

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical treatment of Hemmorhoid	Hemorrhoidectomy, Thrombectomy , Operation on Longo method	Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
Conservative treatment of Hemmorhoid	Detralex	Patients taken conservative treatment (Detralex)
Combined treatment of Hemmorhoid	Combined therapy	Combined treatment patients (surgery and conservative treatment)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pirogov National Surgery Center; 🇷🇺 Moscow, Pervomaisrfya 70, Russian Federation