Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency

Launched by CENTRE HOSPITALIER DEPARTEMENTAL VENDEE · Aug 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating hemorrhoids using a technique called radiofrequency thermodestruction, which aims to reduce postoperative pain. The researchers want to find out if patients can safely skip a pain-relief injection around the anal area (called perianal infiltration) during this procedure, as this injection can have some risks, like infection or allergic reactions. The goal is to see if not using this injection still leads to good results and comfort for patients after the procedure.

To participate in this trial, you need to be an adult (18 years or older) scheduled for the radiofrequency treatment for hemorrhoids. You should also be able to understand the study and give your consent to join. Participants can expect to undergo the radiofrequency procedure, which is designed to be minimally invasive and typically allows them to go home the same day. It's important to note that certain individuals, such as those with previous hemorrhoid surgeries or certain medical conditions, may not be eligible to participate.

Gender

ALL

Eligibility 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
• 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