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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743311
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hemorrhoids Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method Drug: Detralex Other: Combined therapy

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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




Primary Outcome Measures :
  1. Changes in the quality of life of patients suffering from acute or chronic hemorrhoids within 1 month after presenting to a doctor [ Time Frame: 1 month after presenting to a doctor ]
    QoL assessment using the SF36 scale questioner ( assessment of QoL quastions) - added to the Referance


Secondary Outcome Measures :
  1. Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who underwent surgical intervention, within 1 month after presenting to a doctor [ Time Frame: 1 month after presenting to a doctor ]
    QoL assessment using the SF36 scale questioner ( assessment of QoL quastions) - added to the Referance

  2. Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who received conserative treatment, within 1 month after presenting to a doctor. [ Time Frame: 1 month after presenting to a doctor ]
    QoL assessment using the SF36 scale questioner ( assessment of QoL quastions) - added to the Referance

  3. Changes in the QoL of patients suffering from acute or chronic hemorrhoids, who received combination treatment, within 1 month after presenting to a doctor [ Time Frame: 1 month after presenting to a doctor ]
    QoL assessment using the SF36 scale questioner ( assessment of QoL quastions) - added to the Referance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute or chronic hemorrhoids.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743311


Contacts
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Contact: Yuriy Stoyko, prof +7 (499) 464-03-03 ystoyko@mail.ru

Locations
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Russian Federation
Pirogov National Surgery Center Recruiting
Moscow, Pervomaisrfya 70, Russian Federation, 105203
Contact: Yuriy Stoyko, PROF    +7(495)4641054      
Sponsors and Collaborators
Servier Russia

Study Data/Documents: the SF36 scale questioner  This link exits the ClinicalTrials.gov site
The scale the SF36 scale questioner can be sent by email.

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Responsible Party: Servier Russia
ClinicalTrials.gov Identifier: NCT03743311    
Other Study ID Numbers: IC4 -05682-058-RUS
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases