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Multicenter Study
. 2023 Oct;27(10):873-883.
doi: 10.1007/s10151-023-02787-1. Epub 2023 Apr 2.

French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease

A Laurain  1   2 , D Bouchard  3 , J-M Rouillon  4 , P Petit  5 , A Liddo  6   7 , B Vinson Bonnet  8 , A Venara  9 , J-M Didelot  10   11 , G Bonnaud  12 , A Senéjoux  13 , T Higuero  14   15 , P Delasalle  16 , A-L Tarrerias  17 , F Devulder  18 , A Castinel  19 , C Thomas  20   21 , H Pillant Le Moult  22   21 , C Favreau-Weltzer  3 , L Abramowitz  22   23
Affiliations
Multicenter Study

French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease

A Laurain et al. Tech Coloproctol. 2023 Oct.

Abstract

Purpose: The aim of this study was to evaluate the efficacy and safety of radiofrequency ablation (RFA) in the management of haemorrhoidal disease with 1 year's follow-up.

Method: This prospective multicentre study assessed RFA (Rafaelo©) in outpatients with grade II-III haemorrhoids. RFA was performed in the operating room under locoregional or general anaesthesia. Primary endpoint was the evolution of a quality-of-life score adapted to the haemorrhoid pathology (HEMO-FISS-QoL) 3 months after surgery. Secondary endpoints were evolution of symptoms (prolapsus, bleeding, pain, itching, anal discomfort), complications, postoperative pain and medical leave.

Results: A total of 129 patients (69% men, median age 49 years) were operated on in 16 French centres. Median HEMO-FISS-QoL score dropped significantly from 17.4/100 to 0/100 (p < 0.0001) at 3 months. At 3 months, the rate of patients reporting bleeding (21% vs. 84%, p < 0.001), prolapse (34% vs. 91.3%, p < 0.001) and anal discomfort (0/10 vs. 5/10, p < 0.0001) decreased significantly. Median medical leave was 4 days [1-14]. Postoperative pain was 4/10, 1/10, 0/10 and 0/10 at weeks 1, 2, 3 and 4. Seven patients (5.4%) were reoperated on by haemorrhoidectomy for relapse, and three for complications. Reported complications were haemorrhage (3), dysuria (3), abscess (2), anal fissure (1), external haemorrhoidal thrombosis (10), pain requiring morphine (11). Degree of satisfaction was high (+ 5 at 3 months on a - 5/+ 5 scale).

Conclusion: RFA is associated with an improvement in quality of life and symptoms with a good safety profile. As expected for minimally invasive surgery, postoperative pain is minor with short medical leave.

Clinical trial registration and date: Clinical trial NCT04229784 (18/01/2020).

Keywords: Haemorrhoids; Radiofrequency ablation; Rafaelo© procedure; Surgery.

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Conflict of interest statement

Abramowitz Laurent, Laurain Anne and Dominique Bouchard are consultants for F Care. Aurelien Venara is consultant for Intuitive surgery, Sanofi Aventis, Takeda, Thermofisher. Guillaume Bonnaud is consultant for Abbvie, Alfasigma, Bouchara Recordatti, Celltrion, Ferring, Janssen, Gilead, Medtronic, MSD, Norgine, PFIZER, Roche, Takeda, Tillotts. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Surgical procedure. a Preoperative view. b Insertion of the HPR45i probe into the haemorrhoidal bundle 1 cm above the dentate line and tilting of the haemorrhoid away from the sphincter. c Postoperative view
Fig. 2
Fig. 2
Study flowchart
Fig. 3
Fig. 3
Box plot of HEMO-FISS-QoL score before surgery and 1, 3, 6 and 12 months after surgery
See this image and copyright information in PMC

References

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