About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
patients with haemorrhoids undergoing minimally invasive surgical interventions
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The pain syndrome severity score (spontaneous pain) of the visual analog scale (VAS)
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)
Secondary outcomes
Pain syndrome - Spontaneous pain(1)
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. 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)
Pain syndrome - Spontaneous pain (2)
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. 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)
Use of analgesics
The proportion (%) of patients continuing to take analgesics on days 7 after the intervention as compared with the baseline value at the V0 visit.
Use of analgesics
The proportion (%) of patients continuing to take analgesics on days 14 after the intervention as compared with the baseline value at the V0 visit.
Sponsors and contacts
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