Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions (DEMAND HD)
2026년 6월 9일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
200
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: OLGA LINNIK
- 전화번호: 495 9370700
- 이메일: olga.linnik@servier.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
확률 샘플
연구 인구
patients with haemorrhoids undergoing minimally invasive surgical interventions
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
기간: 7 days
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain syndrome - Spontaneous pain(1)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 7 days
|
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)
기간: 14 days
|
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)
기간: 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)
기간: 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.
|
7 days
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Perianal edema (2)
기간: 14 days
|
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)
기간: 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)
기간: 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
|
|
Pain syndrome - Pain related to defecation (2)
기간: 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.
|
14 days
|
|
Pain syndrome - Pain related to defecation (3)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Ivan KOSTAREV, A.N. Ryzhikh National Medical Research Center of Proctology
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 11월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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