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Evaluation of the value of perianal infiltration during thermodestruction of hemorrhoidal disease by Radiofrequency (RAFAELO® procedure)

Phase 1
Conditions
hemorrhoidal disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Registration Number
CTIS2024-514117-35-00
Lead Sponsor
Centre Hospitalier Departemental Vendee
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
134
Inclusion Criteria

Patients over 18, Patients scheduled for thermodestructive hemorrhoidal surgery (RAFAELO® procedure), Patient able to understand the protocol and having given written informed consent to participate in the study, Patient affiliated to the social security system or entitled beneficiary

Exclusion Criteria

Patient < 18 years, Previous hemorrhoidectomy surgery (LONGO technique), Patient with previous pexy ligation procedure (HAL-RAR technique), Patients with known hypersensitivity to local anaesthetics or their ingredients, Patient on long-term (>1 month) analgesic treatment (Level II and III), Patient participating in another interventional clinical research protocol involving a drug or a clinical investigation of a medical device, Pregnant, breast-feeding or childbearing patient without contraception, Patient under guardianship or deprived of liberty

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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