Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions (DEMAND HD)
9 giugno 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
200
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: OLGA LINNIK
- Numero di telefono: 495 9370700
- Email: olga.linnik@servier.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
patients with haemorrhoids undergoing minimally invasive surgical interventions
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain syndrome - Spontaneous pain(1)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
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14 days
|
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Bleeding (3)
Lasso di tempo: 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.
|
25 days
|
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Perianal edema (1)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
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Pain syndrome - Pain related to defecation (3)
Lasso di tempo: 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.
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25 days
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Ivan KOSTAREV, A.N. Ryzhikh National Medical Research Center of Proctology
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 novembre 2026
Completamento dello studio (Stimato)
1 aprile 2027
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 giugno 2026
Primo Inserito (Effettivo)
15 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IC4-05682-083-RUS
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .