HemorrhoidsEQUALISERNCT03743311
Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease
An observational study of Hemorrhoids, run by Servier Russia at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Hemorrhoidectomy, Thrombectomy , Operation on Longo method, Detralex and Combined therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,032 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2019to 5 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute or chronic hemorrhoids.
Who may be able to join
- Age over 18 years;
- Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Hemorrhoidectomy, Thrombectomy , Operation on Longo method, Detralex, Combined therapy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoidectomy, Thrombectomy , Operation on Longo methodProcedure or surgery
Surgical procedures for treatment of Hemorhoid
DetralexDrug
Conservative treatment of Hemorhoid
Combined therapyOther
Surgical + conservative treatment of Hemorhoid
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment of Hemmorhoid | Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) Receives: Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo method | |
| Conservative treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) Receives: Drug: Detralex | |
| Combined treatment of Hemmorhoid | Combined treatment patients (surgery and conservative treatment) Receives: Other: Combined therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month after presenting to a doctor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Mar 2019
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga LINNIK, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743311
- Sponsor's protocol ID
- IC4 -05682-058-RUS
- Acronym
- EQUALISER
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2018
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03743311
- Acronym / sponsor ID
- EQUALISER / IC4 -05682-058-RUS
- Conditions
- Hemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 29 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment of Hemmorhoid | – | Procedure: Hemorrhoidectomy, Thrombectomy , Operation on Longo methodPatients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) |
| Conservative treatment of Hemmorhoid | – | Drug: DetralexPatients taken conservative treatment (Detralex) |
| Combined treatment of Hemmorhoid | – | Other: Combined therapyCombined treatment patients (surgery and conservative treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute or chronic hemorrhoids.
Key inclusion criteria (7 listed)
- Age over 18 years;
- Providing written information to a patient about inclusion in the program, and his/her consent to participate in it,
- Absence of conditions requiring urgent medical care and not related to hemorrhoids;
- The patient was diagnosed with:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemorrhoidectomy, Thrombectomy , Operation on Longo methodSurgical procedures for treatment of Hemorhoid | Procedure or surgery | Surgical treatment of Hemmorhoid |
| DetralexConservative treatment of Hemorhoid | Drug | Conservative treatment of Hemmorhoid |
| Combined therapySurgical + conservative treatment of Hemorhoid | Other | Combined treatment of Hemmorhoid |
Primary outcome
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)
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga LINNIK study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1 month after presenting to a doctor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.