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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743311
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Servier Russia

Tracking Information
First Submitted Date November 13, 2018
First Posted Date November 16, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date March 1, 2019
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2019)
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
Original Primary Outcome Measures
 (submitted: November 13, 2018)
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 EQ-5D-5L scale (Appendix 1)
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: November 13, 2018)
  • 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 EQ-5D-5L scale (Appendix 1)
  • 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 EQ-5D-5L scale (Appendix 1)
  • 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 EQ-5D-5L scale (Appendix 1)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obtaining of Data on the Impact of Different Treatment Modalities on the Quality of Life of the Patients With Acute and Chronic Hemorrhoid Disease
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
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 Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with acute or chronic hemorrhoids.
Condition Hemorrhoids
Intervention
  • Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method
    Surgical procedures for treatment of Hemorhoid
  • Drug: Detralex
    Conservative treatment of Hemorhoid
  • Other: Combined therapy
    Surgical + conservative treatment of Hemorhoid
Study Groups/Cohorts
  • Surgical treatment of Hemmorhoid
    Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
    Intervention: Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method
  • Conservative treatment of Hemmorhoid
    Patients taken conservative treatment (Detralex)
    Intervention: Drug: Detralex
  • Combined treatment of Hemmorhoid
    Combined treatment patients (surgery and conservative treatment)
    Intervention: Other: Combined therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 18, 2020)
1032
Original Estimated Enrollment
 (submitted: November 13, 2018)
900
Actual Study Completion Date June 5, 2019
Actual Primary Completion Date June 5, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03743311
Other Study ID Numbers IC4 -05682-058-RUS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Servier Russia
Study Sponsor Servier Russia
Collaborators Not Provided
Investigators Not Provided
PRS Account Servier Russia
Verification Date June 2020