Evaluation of the interest of perianal infiltration during thermodestruction of haemorrhoidal disease by Radiofrequency (RAFAELO® procedure)

Phase 1

• Conditions: Hemorrhoidal surgery by thermodestruction; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-006904-34-FR
• Lead Sponsor: Centre Hospitalier Départemental Vendée

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-29
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

- Major patient
- Patient scheduled to undergo hemorrhoidal thermodestruction 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 to it
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

- Patient < 18 years old
- Patient with previous hemorrhoidectomy surgery (LONGO technique)
- Patient with previous pexy ligation surgery (HAL-RAR technique)
- Patients with known hypersensitivity to local anaesthetics or components
- Patient with a long term (>1 month) analgesic treatment (level II and III)
- Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- Patient who is pregnant, breastfeeding or able to procreate without contraception
- Patient under guardianship, curatorship or deprived of liberty

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified