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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006904-34-FR

Enrollment

134

Registered

2022-04-29

Start date

2022-06-23

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Hemorrhoidal surgery by thermodestruction

Interventions

Trade Name: Ropivacaïne Product Name: Ropivacaïne Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Patient 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the pain experienced at H6 post-op. ;Secondary Objective: Compare : 1. The evolution of post-operative pain 2. Complications within 30 days of surgery 3. Time to return to work in active patients 4. Post-operative analgesic and non-steroidal anti-inflammatory drug use 5. Quality of life 1 month after haemorrhoidal surgery;Primary end point(s): Visual Analogue Scale at H6 post-op (6 hours after the start of the operation). ;Timepoint(s) of evaluation of this end point: 6 hours after the start of the operation	—

Measure

Time frame

Main Objective: Compare the pain experienced at H6 post-op. ;Secondary Objective: Compare : 1. The evolution of post-operative pain 2. Complications within 30 days of surgery 3. Time to return to work in active patients 4. Post-operative analgesic and non-steroidal anti-inflammatory drug use 5. Quality of life 1 month after haemorrhoidal surgery;Primary end point(s): Visual Analogue Scale at H6 post-op (6 hours after the start of the operation). ;Timepoint(s) of evaluation of this end point: 6 hours after the start of the operation

—

Secondary

Measure	Time frame
Secondary end point(s): 1. VAS at H3, H12, H24 and M1 post-op 2. Adverse events occurring within 30 days post-operatively. This will include the number of infections, AEs warranting re-hospitalization .... 3. Date of return to work 4. 4. classes of analgesics and NSAIDs taken in the 30 days post-operatively 5. Preoperative and M1 postoperative HEMO-FISS-QoL;Timepoint(s) of evaluation of this end point: H3, H12, H24 and M1 post-op	—

Measure

Time frame

Secondary end point(s): 1. VAS at H3, H12, H24 and M1 post-op 2. Adverse events occurring within 30 days post-operatively. This will include the number of infections, AEs warranting re-hospitalization .... 3. Date of return to work 4. 4. classes of analgesics and NSAIDs taken in the 30 days post-operatively 5. Preoperative and M1 postoperative HEMO-FISS-QoL;Timepoint(s) of evaluation of this end point: H3, H12, H24 and M1 post-op

—

Countries

France

Contacts

Public ContactChloé MOREAU

Centre Hospitalier Départemental Vendée

chloe.moreau@ght85.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026