N/A Completed N=1,032

Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease

hemorrhoids

Source: ClinicalTrials.gov NCT03743311 ↗

Enrolled (actual)

1,032

Serious AEs

0.1%

Results posted

Mar 2021

Primary outcomePrimary: 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

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

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.