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

Status

Completed

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514117-35-00

Enrollment

134

Registered

2024-05-29

Start date

2023-01-10

Completion date

2026-01-15

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhoidal disease

Brief summary

Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.

Interventions

DRUGROPIVACAINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026