NCT07647172

Brief Summary

Evaluation of the effectiveness of micronized purified flavonoid fraction (MPFF) as part of the conservative therapy and impact on quality of life and satisfaction with treatment in the real-life clinical practice in patients with haemorrhoids undergoing minimally invasive surgical interventions

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Haemorrhoids

Outcome Measures

Primary Outcomes (1)

  • The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)

    The change in the pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS) on day 7 after the intervention as compared with the baseline value at the V0 visit.

    7 days

Secondary Outcomes (14)

  • Pain syndrome - Spontaneous pain(1)

    14 days

  • Pain syndrome - Spontaneous pain (2)

    25 days

  • Use of analgesics

    7 days

  • Use of analgesics

    14 days

  • Use of analgesics

    25 days

  • +9 more secondary outcomes

Study Arms (2)

Group N 1

This study is non-interventional and has an observational nature, so randomization is not provided for it. This protocol will use the approach with random allocation of sites into clusters depending on the postoperative treatment strategy, acceptable for an observational study. In order to maintain a balance between the number of patients receiving MPFF and those not receiving any systemic venoactive drug, a random distribution of research sites into two clusters will be performed by compiling a table identical to the randomization tables for clinical trials. The study sites allocated to the first cluster will recruit patients who meet the criteria for the group N 1 - those with planned prescription and use of MPFF after the minimally invasive surgical intervention

Group N 2

The study sites allocated to the second cluster will recruit patients who meet the criteria for the group 2 - those without the planned prescription of any systemic venoactive drugs after the minimally invasive surgical intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with haemorrhoids undergoing minimally invasive surgical interventions

You may qualify if:

  • Males and females aged over 18 years.
  • Absence of conditions requiring urgent medical care.
  • The patient was diagnosed with chronic hemorrhoids of grade 2 or 3 according to Goligher classification.
  • laser vaporization (laser submucosal destruction or ablation);
  • transanal dearterialization (hemorrhoidal artery ligation);
  • transanal dearterialization + laser vaporization (laser submucosal destruction or ablation);
  • transanal dearterialization + sclerotherapy.

You may not qualify if:

  • Pregnancy or breast-feeding, or planning for pregnancy during the study or at least in two months after its completion.
  • Confirmed or suspected malignancy.
  • Severe somatic disorder (of heart or blood vessels, lungs, kidneys, pancreas, or liver), accompanied by the organ function decompensation.
  • Mental disorder.
  • Contraindications for examination.
  • Predicted unwillingness of the patient to follow the protocol of treatment and supervision, poor adherence to treatment.
  • Patient's participation in any interventional/observational study at the present time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ivan KOSTAREV

    A.N. Ryzhikh National Medical Research Center of Proctology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

OLGA LINNIK

CONTACT

495 9370700olga.linnik@servier.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06