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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).*
排除标准
- •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).
研究组 & 干预措施
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
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
结局指标
主要结局
The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
时间窗: 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. visual analogue scale (VAS). a 100 mm long scale, in which the 0 mm point corresponds to the absence of pain (minimum value) and the 100 mm point to maximum, unbearable pain (maximum values)
次要结局
- Pain syndrome - Spontaneous pain(1)(14 days)
- Pain syndrome - Spontaneous pain (2)(25 days)
- Use of analgesics(7 days)
- Use of analgesics(14 days)
- Use of analgesics(25 days)
- Bleeding (1)(7 days)
- Bleeding (2)(14 days)
- Bleeding (3)(25 days)
- Perianal edema (1)(7 days)
- Perianal edema (2)(14 days)
- Perianal edema (3)(25 days)
- Pain syndrome - Pain related to defecation (1)(7 days)
- Pain syndrome - Pain related to defecation (2)(14 days)
- Pain syndrome - Pain related to defecation (3)(25 days)