Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions (DEMAND HD)
2026年6月9日 更新者：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
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
200
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：OLGA LINNIK
- 電話番号：495 9370700
- メール：olga.linnik@servier.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
patients with haemorrhoids undergoing minimally invasive surgical interventions
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain syndrome - Spontaneous pain(1)
時間枠：14 days
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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)
時間枠：25 days
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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
時間枠：7 days
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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
時間枠：14 days
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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
時間枠：25 days
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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)
時間枠：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)
時間枠：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)
時間枠：25 days
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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)
時間枠：7 days
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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)
時間枠：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)
時間枠：25 days
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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)
時間枠：7 days
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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.
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7 days
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Pain syndrome - Pain related to defecation (2)
時間枠：14 days
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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)
時間枠：25 days
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Ivan KOSTAREV、A.N. Ryzhikh National Medical Research Center of Proctology
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月15日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。