N/A
N=1,032
Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease
Hemorrhoids
Bottom Line
View on ClinicalTrials.gov: NCT03743311 ↗Enrolled (actual)
1,032
Serious AEs
0.1%
Results posted
Mar 2021
Primary outcome: 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) — 16.5; 11.1; 13.7; 15.5 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hemorrhoidectomy, Thrombectomy , Operation on Longo method (Procedure); Detralex (Drug); Combined therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
16.5; 11.1; 13.7; 15.5; 6.5; 6.3 | — |
| PRIMARY Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients |
13.8; 9.2; 8.8; 11.5; 6; 12 | — |
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
Eligibility Criteria
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:
- Acute hemorrhoids;
- Exacerbation of chronic hemorrhoids;
- Chronic hemorrhoids
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03743311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.