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

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).

The optimal indication for FiLaC® is high trans-sphincteric fistula-in-ano: a prospective cohort of 69 consecutive patients.

BACKGROUND: The aim of our study was to prospectively evaluate the effectiveness of the Fistula Laser Closure (FiLaC®) technique in patients at high risk of anal incontinence and to determine the predictors of success and the impact of the procedure on anal continence. METHODS: A prospective study was conducted on all patients treated with FiLaC® in our department in May 2016-April 2017, because they were at high risk of anal incontinence after fistulotomy, The fistula was considered healed when the internal and external openings were closed and the patient experienced was no pain or leakage. RESULTS: A total of 69 consecutive patients (34 males) with a median age of 40 years (33-53 years) were included in the study. One patient was lost to follow up. The fistulas were intersphincteric (3%), low (15%) or high (66%) trans-sphincteric, and suprasphincteric (16%). After a median follow-up period of 6.3 months (4.2-9.3), fistula healing was observed in 31 patients (45.6%). In univariate analysis, high trans-sphincteric fistulas (p = 0.007) and age over 50 years (p = 0.034) were significantly associated with healing. In multivariate analysis, only high trans-sphincteric fistulas were a predictive factor of significant success. No new cases of anal incontinence or any worsening in case of pre-existing anal incontinence were observed during follow-up. CONCLUSIONS: FiLaC® is particularly effective in cases of high trans-sphincteric fistulas (60% cure). This technique seems to be the most promising sphincter-saving technique available for this indication.

Guidelines for the treatment of hemorrhoids (short report).

Hemorrhoids are a common medical problem that is often considered as benign. The French Society of Colo-Proctology (Société nationale française de colo-proctologie [SNFCP]) recently revised its recommendations for the management of hemorrhoids (last issued in 2001), based on the literature and consensual expert opinion. We present a short report of these recommendations. Briefly, medical treatment, including dietary fiber, should always be proposed in first intention and instrumental treatment only if medical treatment fails, except in grade ≥III prolapse. Surgery should be the last resort, and the patient well informed of the surgical alternatives, including the possibility of elective ambulatory surgery, if appropriate. Postoperative pain should be prevented by the systematic implementation of a pudendal block and multimodal use of analgesics.