Clinical trial NCT03743311: Data on the Impact of Different Treatment on the Quality of Life of Patients With Acute and Chronic Hemorrhoid Disease
Official title: The Russian Multicenter Observational Program Obtaining of Data on the Impact of Different Treatment Modalities on the Quality of Life of the Patients With Acute and Chronic Hemorrhoid Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute or chronic hemorrhoids.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 1 month after presenting to a doctor
measure: Changes in the Quality of Life During the Treatment (Visit V0 vs Visit V3) Based on Results of All Groups of Patients
timeFrame: 1 month after presenting to a doctor
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Surgery Center
state: Pervomaisrfya 70
Study officials:
name: Olga LINNIK
role: STUDY_CHAIR
References: