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

NCT03743311 | Completed Results

• 1 other identifier: IC4 -05682-058-RUS
• Study Type: observational
• Target: 1,032
• Locations: 1 country
• Sites: 1

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

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Surgical treatment of Hemmorhoid

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

Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method

Conservative treatment of Hemmorhoid

Patients taken conservative treatment (Detralex)

Drug: Detralex

Combined treatment of Hemmorhoid

Combined treatment patients (surgery and conservative treatment)

Other: Combined therapy

Interventions

Hemorrhoidectomy, Thrombectomy , Operation on Longo method PROCEDURE

Surgical procedures for treatment of Hemorhoid

Surgical treatment of Hemmorhoid

Detralex DRUG

Conservative treatment of Hemorhoid

Conservative treatment of Hemmorhoid

Combined therapy OTHER

Surgical + conservative treatment of Hemorhoid

Combined treatment of Hemmorhoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic hemorrhoids.

You may qualify if:

• Age over 18 years;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Pirogov National Surgery Center

Moscow, Pervomaisrfya 70, 105203, Russia

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Hemorrhoidectomy; Thrombectomy; S 5682; Psychotherapy, Multiple

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Olga Linnik
• Organization: AO Servier

olga.linnik@servier.com

+7 495 9370700

Study Officials

• Olga LINNIK

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: March 1, 2019
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: March 29, 2021
• Results First Posted: March 29, 2021

Record last verified: 2021-03

Locations

RU (1)