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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical treatment of Hemmorhoid | Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) |
| |
| Conservative treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) |
| |
| Combined treatment of Hemmorhoid | Combined treatment patients (surgery and conservative treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemorrhoidectomy, Thrombectomy , Operation on Longo method | Procedure | Surgical procedures for treatment of Hemorhoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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Patients with acute or chronic hemorrhoids.
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| Name | Affiliation | Role |
|---|---|---|
| Olga LINNIK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pirogov National Surgery Center | Moscow | Pervomaisrfya 70 | 105203 | Russia |
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| ID | Type | URL | Comment |
|---|---|---|---|
| the SF36 scale questioner | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conservative Treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) Detralex: Conservative treatment of Hemorhoid |
| FG001 | Combined Treatment of Hemmorhoid | Combined treatment patients (surgery and conservative treatment) Combined therapy: Surgical + conservative treatment of Hemorhoid |
| FG002 | Surgical Treatment of Hemmorhoid | Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conservative Treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) Detralex: Conservative treatment of Hemorhoid |
| BG001 | Combined Treatment of Hemmorhoid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | 1 month after presenting to a doctor |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conservative Treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) Detralex: Conservative treatment of Hemorhoid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Diarrhea was considered as serious (medically significant) as it resulted in worsening of post-operative healing and increase of pain syndrome. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olga Linnik | AO Servier | +7 495 9370700 | olga.linnik@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2019 | Oct 29, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2019 | Oct 29, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D061865 | Hemorrhoidectomy |
| D017131 | Thrombectomy |
| C080675 | S 5682 |
| D011616 | Psychotherapy, Multiple |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| Detralex | Drug | Conservative treatment of Hemorhoid |
|
| Combined therapy | Other | Surgical + conservative treatment of Hemorhoid |
|
The scale the SF36 scale questioner can be sent by email. |
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
| BG002 | Surgical Treatment of Hemmorhoid | Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3 | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| patients with acute or chronic hemorrhoids | Count of Participants | Participants |
|
| OG001 | Conservative Treatment of Hemmorhoid | Patients taken conservative treatment (Detralex) Detralex: Conservative treatment of Hemorhoid |
| OG002 | Combined Treatment of Hemmorhoid | Combined treatment patients (surgery and conservative treatment) Combined therapy: Surgical + conservative treatment of Hemorhoid |
|
|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | 1 month after presenting to a doctor |
|
|
|
| 0 |
| 311 |
| 0 |
| 311 |
| 0 |
| 311 |
| EG001 | Combined Treatment of Hemmorhoid | Combined treatment patients (surgery and conservative treatment) Combined therapy: Surgical + conservative treatment of Hemorhoid | 0 | 298 | 0 | 298 | 0 | 298 |
| EG002 | Surgical Treatment of Hemmorhoid | Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.) Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid | 0 | 423 | 1 | 423 | 0 | 423 |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| General health |
|
| Vitality |
|
| Social functioning |
|
| Mental health |
|
| Role emotional |
|