Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions (DEMAND HD)
9 juni 2026 bijgewerkt door: Servier Russia
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
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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Geschat)
200
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: OLGA LINNIK
- Telefoonnummer: 495 9370700
- E-mail: olga.linnik@servier.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
patients with haemorrhoids undergoing minimally invasive surgical interventions
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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
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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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
Tijdsspanne: 7 days
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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.
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7 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain syndrome - Spontaneous pain(1)
Tijdsspanne: 14 days
|
The change in the pain syndrome severity score (spontaneous pain) of VAS on day 14 after the intervention as compared with the baseline value at the V0 visit.
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14 days
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Pain syndrome - Spontaneous pain (2)
Tijdsspanne: 25 days
|
The change in the pain syndrome severity score (spontaneous pain) of VAS on day 25 after the intervention as compared with the baseline value at the V0 visit.
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25 days
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Use of analgesics
Tijdsspanne: 7 days
|
The proportion (%) of patients continuing to take analgesics on days 7 after the intervention as compared with the baseline value at the V0 visit.
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7 days
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Use of analgesics
Tijdsspanne: 14 days
|
The proportion (%) of patients continuing to take analgesics on days 14 after the intervention as compared with the baseline value at the V0 visit.
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14 days
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Use of analgesics
Tijdsspanne: 25 days
|
The proportion (%) of patients continuing to take analgesics on days 25 after the intervention as compared with the baseline value at the V0 visit.
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25 days
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Bleeding (1)
Tijdsspanne: 7 days
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Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 7 day after the intervention as compared with the baseline value at the V0 visit.
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7 days
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Bleeding (2)
Tijdsspanne: 14 days
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Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 14 day after the intervention as compared with the baseline value at the V0 visit.
|
14 days
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Bleeding (3)
Tijdsspanne: 25 days
|
Change in the score of bleeding (frequency, intensity) on the 4-point Likert scale on day 25 day after the intervention as compared with the baseline value at the V0 visit.
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25 days
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Perianal edema (1)
Tijdsspanne: 7 days
|
Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 7 day after the intervention as compared with the baseline value at the V0 visit.
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7 days
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Perianal edema (2)
Tijdsspanne: 14 days
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Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 14 day after the intervention as compared with the baseline value at the V0 visit.
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14 days
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Perianal edema (3)
Tijdsspanne: 25 days
|
Change in the perianal edema score of the 4-point Likert scale (by the objective examination data) on day 25 day after the intervention as compared with the baseline value at the V0 visit.
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25 days
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Pain syndrome - Pain related to defecation (1)
Tijdsspanne: 7 days
|
The change in the pain syndrome severity score (pain related to defecation) of VAS on day 7 after the intervention as compared with the baseline value at the V0 visit.
|
7 days
|
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Pain syndrome - Pain related to defecation (2)
Tijdsspanne: 14 days
|
The change in the pain syndrome severity score (pain related to defecation) of VAS on day 14 after the intervention as compared with the baseline value at the V0 visit.
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14 days
|
|
Pain syndrome - Pain related to defecation (3)
Tijdsspanne: 25 days
|
The change in the pain syndrome severity score (pain related to defecation) of VAS on day 25 after the intervention as compared with the baseline score at the V0 visit.
|
25 days
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ivan KOSTAREV, A.N. Ryzhikh National Medical Research Center of Proctology
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
1 november 2026
Studie voltooiing (Geschat)
1 april 2027
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IC4-05682-083-RUS
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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