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

Официальное название

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

Обзор

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

Подробное описание

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.

Первичные конечные точки

• The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS) [Срок оценки: 7 days]

Вторичные конечные точки (12)

• Pain syndrome - Spontaneous pain(1) [Срок оценки: 14 days]
• Pain syndrome - Spontaneous pain (2) [Срок оценки: 25 days]
• Use of analgesics [Срок оценки: 7 days]
• Use of analgesics [Срок оценки: 14 days]
• Use of analgesics [Срок оценки: 25 days]
• Bleeding (1) [Срок оценки: 7 days]
• Bleeding (2) [Срок оценки: 14 days]
• Bleeding (3) [Срок оценки: 25 days]
• Perianal edema (1) [Срок оценки: 7 days]
• Perianal edema (2) [Срок оценки: 14 days]
• Perianal edema (3) [Срок оценки: 25 days]
• Pain syndrome - Pain related to defecation (1) [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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).\*

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07647172 · IC4-05682-083-RUS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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