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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Drug: Ropivacaine; Other: Failure to perform peri-anal ropivacaine infiltration

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chloé MOREAU; Phone Number: +33 251446327; Email: chloe.moreau@ght85.fr

Study Locations

• France
  • La Roche sur Yon, France
    • Recruiting
    • Centre Hospitalier Départemental VENDEE
    • Principal Investigator: Emeric ABET
  • Nantes, France
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Nantes
    • Principal Investigator: Emilie DUCHALAIS
  • Saint-Nazaire, France
    • Not yet recruiting
    • Clinique Mutualiste de l'Estuaire
    • Principal Investigator: Yann REDON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peri-anal infiltration of Ropivacaine	Drug: Ropivacaine; Peri-anal infiltration of Ropivacaine
Experimental: Failure to perform peri-anal ropivacaine infiltration	Other: Failure to perform peri-anal ropivacaine infiltration; Failure to perform peri-anal ropivacaine infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) of pain	Minimum value = 0 Maximum value = 10	H6 post-op (6 hours after the start of the operation)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Emeric ABET, Centre Hospitalier Départemental VENDEE; Principal Investigator: Farouk DRISSI, Nantes University Hospital; Principal Investigator: Yann REDON, Clinique Mutualiste de l'Estuaire

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CHD21_0121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No