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Not yet recruiting NCT07647172

Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions

— Observational Haemorrhoids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Haemorrhoids. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

This observational program does not imply changes to the common treatment strategy in patients with chronic hemorrhoids. In this observational study, the parameters usually assessed during the examination of patients with grade 2 or 3 chronic hemorrhoids, according to the Goligher classification, will be recorded The observational design of the program assumes that all examinations, procedures and changes to the patient's therapy, including changes in the doses of medications, should be carried out only per decision of the attending physician and in full accordance with existing guidelines for the management of patients of the analysed category, instructions for the medical use of a medicinal product and within the established routine practice.

Primary outcome measures

  • The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS) [Time frame: 7 days]
Secondary outcome measures (12)
  • Pain syndrome - Spontaneous pain(1) [Time frame: 14 days]
  • Pain syndrome - Spontaneous pain (2) [Time frame: 25 days]
  • Use of analgesics [Time frame: 7 days]
  • Use of analgesics [Time frame: 14 days]
  • Use of analgesics [Time frame: 25 days]
  • Bleeding (1) [Time frame: 7 days]
  • Bleeding (2) [Time frame: 14 days]
  • Bleeding (3) [Time frame: 25 days]
  • Perianal edema (1) [Time frame: 7 days]
  • Perianal edema (2) [Time frame: 14 days]
  • Perianal edema (3) [Time frame: 25 days]
  • Pain syndrome - Pain related to defecation (1) [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Males and females aged over 18 years.
  • Informing the patient in writing about the inclusion in the study and his/her consent to participate in it.
  • Absence of conditions requiring urgent medical care.
  • The patient was diagnosed with chronic hemorrhoids of grade 2 or 3 according to Goligher classification.
  • The patient is scheduled to undergo one of the listed types of minimally invasive surgical treatment within 7 ± 2 days from the inclusion in the study (V0):
  • laser vaporization (laser submucosal destruction or ablation);
  • transanal dearterialization (hemorrhoidal artery ligation);
  • transanal dearterialization + laser vaporization (laser submucosal destruction or ablation);
  • transanal dearterialization + sclerotherapy.
  • No venoactive drug treatment within 4 weeks prior to inclusion in the study.
  • The patient has been prescribed with MPFF at the inclusion visit, or it is planned to prescribe MPFF-containing drug in the postoperative period (for cluster 1 sites), or the patient has not been prescribed with any systemic venoactive drug, and it is not planned to prescribe it the postoperative period (for cluster 2 sites).\*

Exclusion criteria

  • 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.
  • Patients who received venoactive drugs in the 4 weeks prior to Visit 0 (inclusion visit).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07647172 · IC4-05682-083-RUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗