دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease.
المؤلفون: Laurain A; Clinique Blomet Ramsay santé, 136 rue Blomet, 75015, Paris, France. anne.laurain@aphp.fr.; Service de Proctologie, Hôpital Bichat, APHP, 46 Rue Henri Huchard, 75018, Paris, France. anne.laurain@aphp.fr., Bouchard D; Service de Proctologie, Hôpital Bagatelle, 33400, Talence, France., Rouillon JM; Service de Gastroentérologie, Polyclinique Montréal, Route de Bram, 11000, Carcassonne, France., Petit P; Clinique Santé Atlantique, Elsan, 44800, Saint Herblain, France., Liddo A; Cabinet médical, 1 Quai du Havre, 59200, Tourcoing, France.; Clinique de la Victoire, 1 Quai du Havre, 59200, Tourcoing, France., Vinson Bonnet B; Service de Chirurgie Digestive CHI Poissy, St Germain, France., Venara A; Service de Chirurgie Viscérale et Endocrinienne CHU Angers, 4 rue Larrey, Angers, France., Didelot JM; Cabinet médical, 1019 Avenue du Pr Louis Ravaz, 34080, Montpellier, France.; Clinique Clémentville, 25 Rue de Clémentville, 34070, Montpellier, France., Bonnaud G; Clinique Ambroise Paré, 31000, Toulouse, France., Senéjoux A; Centre Hospitalier Privé, 6 Bd de la Boutière, 35760, Saint Grégoire, France., Higuero T; Cabinet médical, 11, bd du général Leclerc, 06240, Beausoleil, France.; Clinique Kantys centre, 7 avenue Durante, 06004, Nice, France., Delasalle P; Clinique du Palais, 25 Avenue Chiris, 06130, Grasse, France., Tarrerias AL; Clinique du Trocadéro, 75016, Paris, France., Devulder F; SELARL Hépato-gastroentérologie, 89 rue Louis Victor de Broglie, 51430, Bezannes, France., Castinel A; Service de Proctologie, Clinique Tivoli Ducos, 91 rue de Rivière, Bordeaux, France., Thomas C; Service d'Hépato-gastroentérologie, Institut mutualiste Montsouris, 40 boulevard Jourdan, 75014, Paris, France.; Service de Proctologie, Hôpital St Joseph rue Losserand, 75014, Paris, France., Pillant Le Moult H; Clinique Blomet Ramsay santé, 136 rue Blomet, 75015, Paris, France.; Service de Proctologie, Hôpital St Joseph rue Losserand, 75014, Paris, France., Favreau-Weltzer C; Service de Proctologie, Hôpital Bagatelle, 33400, Talence, France., Abramowitz L; Clinique Blomet Ramsay santé, 136 rue Blomet, 75015, Paris, France.; Service de Proctologie, Hôpital Bichat, APHP, 46 Rue Henri Huchard, 75018, Paris, France.
المصدر: Techniques in coloproctology [Tech Coloproctol] 2023 Oct; Vol. 27 (10), pp. 873-883. Date of Electronic Publication: 2023 Apr 02.
نوع المنشور: Multicenter Study; Journal Article
اللغة: English
بيانات الدورية: Publisher: Springer-Verlag Italia Country of Publication: Italy NLM ID: 9613614 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1128-045X (Electronic) Linking ISSN: 11236337 NLM ISO Abbreviation: Tech Coloproctol Subsets: MEDLINE
أسماء مطبوعة: Publication: <2001->: Milano, Italy : Springer-Verlag Italia
Original Publication: Rome : UCP Club,
مواضيع طبية MeSH: Hemorrhoids*/surgery , Hemorrhoids*/complications , Hemorrhoidectomy*/adverse effects , Radiofrequency Ablation*/adverse effects, Male ; Humans ; Middle Aged ; Female ; Quality of Life ; Pain, Postoperative/etiology ; Treatment Outcome
مستخلص: 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).
(© 2023. The Author(s).)
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فهرسة مساهمة: Keywords: Haemorrhoids; Radiofrequency ablation; Rafaelo© procedure; Surgery
سلسلة جزيئية: ClinicalTrials.gov NCT04229784
تواريخ الأحداث: Date Created: 20230403 Date Completed: 20230911 Latest Revision: 20231221
رمز التحديث: 20231221
مُعرف محوري في PubMed: PMC10485119
DOI: 10.1007/s10151-023-02787-1
PMID: 37005961
قاعدة البيانات: MEDLINE
الوصف
تدمد:1128-045X
DOI:10.1007/s10151-023-02787-1