Hemorrhoids
Conditions
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
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.
Interventions
DRUGDetralex
Conservative treatment of Hemorhoid
PROCEDUREHemorrhoidectomy, Thrombectomy , Operation on Longo method
Surgical procedures for treatment of Hemorhoid
OTHERCombined therapy
Surgical + conservative treatment of Hemorhoid
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conservative Treatment of Hemmorhoid Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid | 311 |
| Combined Treatment of Hemmorhoid Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid | 298 |
| 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 | 423 |
| Total | 1,032 |
Baseline characteristics
| Characteristic | Conservative Treatment of Hemmorhoid | Combined Treatment of Hemmorhoid | Surgical Treatment of Hemmorhoid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 24 Participants | 27 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 289 Participants | 274 Participants | 396 Participants | 959 Participants |
| Age, Continuous | 42.9 years | 44.2 years | 46.9 years | 44.9 years |
| patients with acute or chronic hemorrhoids | 311 Participants | 298 Participants | 423 Participants | 1032 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Russia | 311 Participants | 298 Participants | 423 Participants | 1032 Participants |
| Sex: Female, Male Female | 171 Participants | 139 Participants | 209 Participants | 519 Participants |
| Sex: Female, Male Male | 138 Participants | 159 Participants | 211 Participants | 508 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 311 | 0 / 298 | 0 / 423 |
| other Total, other adverse events | 0 / 311 | 0 / 298 | 0 / 423 |
| serious Total, serious adverse events | 0 / 311 | 0 / 298 | 1 / 423 |
Outcome results
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.
Time frame: 1 month after presenting to a doctor
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Physical functioning | 13.8 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Role physical | 9.2 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Bodily pain | 8.8 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | General health | 11.5 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Vitality | 6 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Social functioning | 12 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Mental health | 11.4 units on a scale |
| Surgical Treatment of Hemmorhoid | Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients | Role emotional | 17.5 units on a scale |
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.
Time frame: 1 month after presenting to a doctor
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Surgical Treatment of Hemmorhoid | 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) | Physical functioning | 16.5 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Role physical | 15.5 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Bodily pain | 19.8 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | General health | 13 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Vitality | 7.2 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Social functioning | 18.4 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Role emotional | 30.4 units on a scale |
| Surgical Treatment of Hemmorhoid | 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) | Mental health | 14.4 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Bodily pain | 3.9 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Role emotional | 12.8 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | General health | 9.7 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Vitality | 3.9 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Social functioning | 10.4 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Physical functioning | 11.1 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Role physical | 6.5 units on a scale |
| Conservative Treatment of Hemmorhoid | 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) | Mental health | 8.7 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Bodily pain | 1.8 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Role physical | 6.3 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Physical functioning | 13.7 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | General health | 11.6 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Role emotional | 11.4 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Social functioning | 8.2 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Vitality | 6.5 units on a scale |
| Combined Treatment of Hemmorhoid | 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) | Mental health | 11 units on a scale |