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

Hemorrhoids Clinical Trial

— RAFAELOCAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519189
• Other study ID #: CHD21_0121
• Status: Recruiting
• Phase: Phase 4
• Start date: January 10, 2023
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: Chloé MOREAU
• Phone: 251446327
• Email: chloe.moreau[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Haemorrhoidal disease is a common and benign condition (1). Anatomically, there is an external and internal component. Only internal haemorrhoidal disease is managed by radiofrequency. Different levels of severity of internal haemorrhoidal disease have been defined by the Goligher classification (1). According to the recommendations for clinical practice established by the French National Society of ColoProctology (SNFCP), grade I and II haemorrhoidal disease should be managed instrumentally after failure of medical treatment. Grade III and IV haemorrhoidal disease is an indication for surgical management in the first instance or after failure of instrumental treatments. The standard technique is the Milligan and Morgan procedure (pedicle haemorrhoidectomy) described in 1937 (2). This technique consists of the removal of the 3 internal haemorrhoidal bundles. It remains the most effective but is responsible for postoperative complications, in particular pain, haemorrhage, anal strictures and anal incontinence (3), (4). Less aggressive techniques have been developed (Longo technique, HAL-RAR technique). The Longo technique is a circular stapling haemorrhoidopexy. The haemorrhoidal packets are brought up into the anal canal with the help of a circular aggravating forceps removing a collar of rectal mucosa. This removal of the mucosa also allows the vascularisation of the haemorrhoidal venous network to be interrupted. The HAL- RAR technique is a non-resection technique consisting of arterial ligation of the haemorrhoidal packets in order to interrupt the vascularisation supplying the haemorrhoidal packets. This technique can be performed with or without Doppler guidance. Recently, Renshaw et al. described a technique for coagulation of haemorrhoidal bundles using a radiofrequency probe (5).

This technique has shown satisfactory results and is an interesting option in the management of haemorrhoidal disease (6) with low postoperative pain (7).

In order to limit patients' postoperative pain and reduce their apprehension during defecation episodes, a perianal block has been shown to reduce postoperative pain in patients with a haemorrhoidectomy technique (8,9). In 2019, a prospective randomised trial (10) confirmed the value of this perianal block without a neurostimulator during a haemorrhoidal pack resection procedure. A perianal infiltration of 40 ml of 0.5% Ropivacaine was performed. These 40ml were divided into 4 injections of 10ml each in the left and right antero-lateral position and in the left and right postero-lateral position in relation to the anal margin.

The hemorrhoidal pack resection technique is known to induce postoperative pain. Haemorrhoidal radiofrequency (RAFAELO® procedure) is a new minimally invasive technique that reduces postoperative pain and is usually performed on an outpatient basis (6). Currently, peri-anal infiltration is routinely performed for all haemorrhoidal surgery whether or not there is a haemorrhoidal resection. No studies have evaluated the relevance of maintaining peri-anal infiltration in non-resected haemorrhoidal surgery and in particular during radiofrequency haemorrhoidal packets. In addition, ropivacaine infiltration is not without risks. Local anaesthesia has potential risks for the patient:

• Adverse reaction or hypersensitivity to local anaesthetics and components

• Infection at the injection site or infiltration

• Haematoma at the injection or infiltration site The aim of our study is to demonstrate the non-inferiority of discontinuing perianal infiltration in patients with thermodestructive haemorrhoidal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Ropivacaine
Peri-anal infiltration of Ropivacaine

Other:
• Failure to perform peri-anal ropivacaine infiltration
Failure to perform peri-anal ropivacaine infiltration

Locations

Country	Name	City	State
France	Centre Hospitalier Départemental Vendée	La Roche sur Yon
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Clinique Mutualiste de l'Estuaire	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) of pain	Minimum value = 0 Maximum value = 10	H6 post-op (6 hours after the start of the operation)