Trial Outcomes & Findings for Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease (NCT NCT03743311)
NCT ID: NCT03743311
Last Updated: 2021-03-29
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1032 participants
Primary outcome timeframe
1 month after presenting to a doctor
Results posted on
2021-03-29
Participant Flow
Participant milestones
| Measure |
Conservative Treatment of Hemmorhoid
Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid
|
Combined Treatment of Hemmorhoid
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
311
|
298
|
423
|
|
Overall Study
COMPLETED
|
311
|
298
|
423
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
Baseline characteristics by cohort
| Measure |
Conservative Treatment of Hemmorhoid
n=311 Participants
Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid
|
Combined Treatment of Hemmorhoid
n=298 Participants
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
|
Surgical Treatment of Hemmorhoid
n=423 Participants
Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid
|
Total
n=1032 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=311 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=423 Participants
|
0 Participants
n=1032 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
289 Participants
n=311 Participants
|
274 Participants
n=298 Participants
|
396 Participants
n=423 Participants
|
959 Participants
n=1032 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=311 Participants
|
24 Participants
n=298 Participants
|
27 Participants
n=423 Participants
|
73 Participants
n=1032 Participants
|
|
Age, Continuous
|
42.9 years
n=311 Participants
|
44.2 years
n=298 Participants
|
46.9 years
n=423 Participants
|
44.9 years
n=1032 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=309 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
139 Participants
n=298 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
209 Participants
n=420 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
519 Participants
n=1027 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
|
Sex: Female, Male
Male
|
138 Participants
n=309 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
159 Participants
n=298 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
211 Participants
n=420 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
508 Participants
n=1027 Participants • There is no data about sex of 2 participants in Group 1 There is no data about sex of 3 participants in Group 3
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
311 Participants
n=311 Participants
|
298 Participants
n=298 Participants
|
423 Participants
n=423 Participants
|
1032 Participants
n=1032 Participants
|
|
patients with acute or chronic hemorrhoids
|
311 Participants
n=311 Participants
|
298 Participants
n=298 Participants
|
423 Participants
n=423 Participants
|
1032 Participants
n=1032 Participants
|
PRIMARY outcome
Timeframe: 1 month after presenting to a doctorThe 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.
Outcome measures
| Measure |
Surgical Treatment of Hemmorhoid
n=311 Participants
Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid
|
Conservative Treatment of Hemmorhoid
n=298 Participants
Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid
|
Combined Treatment of Hemmorhoid
n=423 Participants
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
|
|---|---|---|---|
|
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
Interval 3.4 to 29.6
|
11.1 units on a scale
Interval 2.7 to 19.5
|
13.7 units on a scale
Interval 6.4 to 21.0
|
|
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
Interval 10.0 to 21.0
|
6.5 units on a scale
Interval 3.8 to 9.2
|
6.3 units on a scale
Interval 6.0 to 6.6
|
|
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
Interval 13.2 to 26.4
|
3.9 units on a scale
Interval 0.5 to 7.3
|
1.8 units on a scale
Interval 1.0 to 4.6
|
|
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
Interval 6.4 to 19.6
|
9.7 units on a scale
Interval 8.2 to 11.2
|
11.6 units on a scale
Interval 9.1 to 14.1
|
|
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
Interval 5.0 to 9.4
|
3.9 units on a scale
Interval 2.2 to 5.6
|
6.5 units on a scale
Interval 4.9 to 8.1
|
|
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
Interval 9.2 to 27.6
|
10.4 units on a scale
Interval 5.2 to 15.6
|
8.2 units on a scale
Interval 5.3 to 11.1
|
|
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
Interval 17.9 to 42.9
|
12.8 units on a scale
Interval 5.5 to 18.5
|
11.4 units on a scale
Interval 8.5 to 14.3
|
|
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
Interval 8.3 to 20.5
|
8.7 units on a scale
Interval 5.6 to 11.8
|
11 units on a scale
Interval 6.3 to 15.7
|
PRIMARY outcome
Timeframe: 1 month after presenting to a doctorQoL 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.
Outcome measures
| Measure |
Surgical Treatment of Hemmorhoid
n=1032 Participants
Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid
|
Conservative Treatment of Hemmorhoid
Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid
|
Combined Treatment of Hemmorhoid
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
|
|---|---|---|---|
|
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
Interval 5.6 to 22.0
|
—
|
—
|
|
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
Interval 7.6 to 10.8
|
—
|
—
|
|
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
Interval 5.4 to 12.2
|
—
|
—
|
|
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
Interval 8.9 to 14.1
|
—
|
—
|
|
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
Interval 4.1 to 7.9
|
—
|
—
|
|
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
Interval 6.8 to 17.2
|
—
|
—
|
|
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
Interval 6.7 to 16.1
|
—
|
—
|
|
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
Interval 11.4 to 23.6
|
—
|
—
|
Adverse Events
Conservative Treatment of Hemmorhoid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combined Treatment of Hemmorhoid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgical Treatment of Hemmorhoid
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conservative Treatment of Hemmorhoid
n=311 participants at risk
Patients taken conservative treatment (Detralex)
Detralex: Conservative treatment of Hemorhoid
|
Combined Treatment of Hemmorhoid
n=298 participants at risk
Combined treatment patients (surgery and conservative treatment)
Combined therapy: Surgical + conservative treatment of Hemorhoid
|
Surgical Treatment of Hemmorhoid
n=423 participants at risk
Patients after surgical treatment (Instrumental Invasive Surgical Procedures or Thrombectomy, Hemorrhoidectomy etc.)
Hemorrhoidectomy, Thrombectomy , Operation on Longo method: Surgical procedures for treatment of Hemorhoid
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/311 • 3 months
|
0.00%
0/298 • 3 months
|
0.24%
1/423 • Number of events 1 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place