Evaluation of the Effectiveness of Micronized Purified Flavonoid Fraction (MPFF) in Patients With Haemorrhoids Undergoing Minimally Invasive Surgical Interventions

ConditionHaemorrhoids
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorServier Russia

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Group N 1
Group B: Group N 2

Trial outcomes

Primary outcomes

1

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)

Time frame
7 days

Secondary outcomes

1

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)

Time frame
14 days
2

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)

Time frame
25 days
3

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.

Time frame
7 days
4

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.

Time frame
14 days

Other outcomes

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