What can patients expect in the long term from radiofrequency thermocoagulation of hemorrhoids on bleeding, prolapse, quality of life, and recurrence: “no pain, no gain” or “no pain but a gain”?
Article information
Abstract
Purpose
The purpose of this study was to assess the long-term efficacy of hemorrhoidal radiofrequency thermocoagulation (RFT) on bleeding, prolapse, quality of life (QoL), and recurrence.
Methods
This retrospective, single-center study, with RFT performed using procedure modified via hemorrhoid exteriorization assessed the evolution of hemorrhoidal prolapse rated by Goligher scale; bleeding and discomfort (0–10), feeling of improvement and satisfaction (–5 to +5/5) by analog scales; the impact of hemorrhoids on QoL by HEMO-FISS-QoL score.
Results
From April 2016 to January 2021, 124 patients underwent surgery and 107 could be interviewed in September 2021. The average follow-up was 30 months (range, 8–62 months). The mean work stoppage was 3 days, none in 71.0% of the cases. A mean of 4,334 J was applied. No analgesics were required for 66.4% of patients. External hemorrhoidal thrombosis was the only immediate complication in 9 patients, with no long-term reported complication. Bleeding disappeared in 53 out of 102 patients or dropped from 7 to 3/10 (P<0.001). Prolapse reduced from mean grade 3 to 2 (P<0.001), discomfort from 7 to 2/10 (P<0.001). HEMO-FISS-QoL score improved from 22 to 7/100 (P<0.001). Feeling of improvement and overall satisfaction rate are +4/5. Recurrence occurred in 21.5% of patients at 22 months, and 6 required reoperation. Of the patients, 91.6% would choose the same procedure again and 96.3% recommend it.
Conclusion
RFT, although imperfect, leads to a significant improvement in hemorrhoidal symptoms and a lasting increase in QoL with minimal pain and downtime, high acceptance, and low complication and recurrence rates.
INTRODUCTION
Hemorrhoidal disease is the most common pathology of the anus, affecting approximately 10% to 40% of the general population [1-5]. Although physiological, internal hemorrhoids can cause troublesome symptoms, especially bleeding and prolapse, the most frequently reported symptoms, and can have a major impact on quality of life (QoL) or serious consequences in case of anemia secondary to frequent and/or heavy bleeding. Their management ranges from a topical medical treatment with hygienic-dietary rules [6-9] to radical surgery, represented almost exclusively from 1937 to 1998 by open [10] or semiclosed [11] hemorrhoidectomy. However, in these procedures, scarring lasts 4 to 8 weeks, postoperative pain is often in the foreground and frightens patients, and expose them to early (hemorrhages) or late severe complications (anal incontinence, anal stenosis). In order to reduce these postoperative complications and disability time, other surgical techniques were developed, such as Longo hemorrhoidopexy [12], Doppler-controlled hemorrhoidal artery ligation (DGHAL) [13-16], laser hemorrhoidoplasty [17, 18], and hemorrhoidal laser procedure (HeLP) technique [19]. A new procedure called Rafaelo (F-Care-Systems, Antwerp, Belgium) using radiofrequency thermocoagulation (RFT) was recently proposed as an additional alternative to standard hemorrhoidectomy.
This study was performed to determine the long-term efficacy of RFT on internal hemorrhoidal bleeding and prolapse, its impact on QoL, its feasibility in outpatient settings, the downtime and consumption of analgesics it imposes, its possible early and late complications, and its rate of recurrence. Extension of the first one performed in France in 2018 on RFT [20], it allows judging the evolution of the results obtained over time.
METHODS
Ethics
The study was conducted in accordance with the Declaration of Helsinki and good clinical practice. The ethics committee of the Biomedical Research Institute, University Hospital in Nîmes, France approved its protocol (No. study 21.07.01). All patients received the necessary explanations upon intervention, expected benefits, and risks before the procedure and gave written consent.
Study design
This single-center (Clémentville Clinic, Montpellier, France), retrospective study includes all patients operated on between April 2016 and January 2021 (including the first 42 patients operated on between April 2016 and April 2018 already studied in September 2018 [20]). They represent the all-consecutive patients consulting for hemorrhoidal pathology, eligible for surgery and having opted for RFT among other proposals (Milligan-Morgan, DGHAL, or hemorrhoidopexy). These patients had either hemorrhoidal prolapse and/or bleeding that resisted the usual hygienic-dietary rules, topical treatments, and rubber band ligations. Exclusion criteria were predominant external hemorrhoidal thromboses or anal fissures.
Pre- and intraoperative data were systematically recorded, including evaluation of hemorrhoidal prolapse following the Goligher scale (1–4) [21], bleeding intensity, number of hemorrhoids treated, energy delivered, and intraoperative complications.
Then, all patients were followed up for 4 to 8 weeks postoperatively as outpatients (which allowed to collect data about work stoppage, complications, bleeding, and prolapse) and, in May 2021, received information by mail before a telephone interview conducted between May and September 2021, by a gastroenterology resident who did not know the patients to limit interview biases.
This data collection recovered preoperative and postoperative information on hemorrhoidal prolapse always following the Goligher scale. Bleeding and overall anal discomfort were noted by the patients according to a verbal analog scale using a validated “proctological symptom scale” ranging from 0 (absence) to 10 (very important) [22]. They also rated the effectiveness of the treatment and their satisfaction on another verbal analog scale (from –5, deterioration to +5, improvement). Finally, the impact of the hemorrhoidal pathology on QoL was evaluated with HEMO-FISS-QoL score (0–100) via the validated HEMO-FISSQoL questionnaire [23] and represents the primary endpoint of the study.
At last, a comparison was achieved between the results obtained for the first 42 patients operated on [20] and all the patients finally included.
Surgical technique
All patients were operated on under general anesthesia according to a modified Rafaelo procedure, not through an anoscope as described in the original technique but after exteriorization of the hemorrhoidal bundles at the anal margin (Fig. 1). After injection of 2% lidocaine, an HPR45i probe (F-Care-Systems) was introduced into the hemorrhoids upstream of the pectineal line at an angle of 30°. A generator delivered a low-temperature radiofrequency wave (4 MHz) in 10 to 20-second pulses followed by dabbing each hemorrhoidal pack with a compress soaked in ice-cold saline to limit the diffusion of the thermocoagulation. Tissue fibrosis begins as soon as the procedure is completed but continues for several weeks, with the final result not being estimated until the 3rd or 4th postoperative week [24, 25]. Arbitrarily, it has been tried not to exceed 1,500 J per hemorrhoidal pack. Each procedure systematically treated 4 columns (right anterior, right posterior, median posterior, and left lateral).
Intervention using hemorrhoidal radiofrequency thermocoagulation with the HPR45i probe (F-Care-Systems, Antwerp, Belgium) with externalization of internal hemorrhoids.
Statistics
Frequencies and percentages for categorical variables and means and standard deviations for continuous variables describe the study sample after assessing the normality of the data using the Shapiro-Wilk test. Analysis of changes before and after RFT was performed using Student t-test for paired series. Comparisons between groups were made using the Student t-test (or Mann-Whitney test where appropriate) for continuous criteria and using the chi-square test (or Fisher exact test if applicable) for categorical criteria. Relationships between continuous variables were studied using Pearson r correlation coefficient (or Spearman where appropriate). Analysis of a learning effect was performed by distinguishing 4 time-ordered periods of equivalent size. Recurrence was analyzed using survival methods, taking the date of intervention as the starting point, considering time to recurrence or time to the last report. The survival curve was plotted using the Kaplan-Meier method. Recurrence factors analysis was conducted using the log-rank test for categorical variables and a Cox model for continuous variables. A multivariate Cox proportional hazards model was performed, adjusting for clinical relevance of criteria and statistically highlighted in the univariate analysis. All tests were 2-tailed, and a P-value of < 0.05 was considered statistically significant. Statistical analysis was carried out with Stata ver. 15 (Stata Corp, College Station, TX, USA).
RESULTS
General data, work stoppage and pain
Between April 2016 and January 2021, 124 patients underwent hemorrhoidal RFT. Among them, 107 patients with mean age of 54.0±12.8 years (range, 22–82 years) could be reached and answered the telephone questionnaire, including 75 male and 32 female patients (Table 1). The average follow-up was 30±14 months (range, 8–62 months).
Descriptive analysis of the studied population
The vast majority of procedures (86.0%) were performed on an outpatient basis. The remaining 14.0% of patients were excluded from the ambulatory program before surgery because of noncompliance with French outpatient rules (comorbidity or distance from home).
In total, the average duration of work stoppage was 3.0±10.6 days, with 71.0% of patients able to resume their activity the day after the operation. Concerning postoperative pain, 66.4% of the patients did not take any level II analgesic. No morphine was required.
Complications
Data collection shows very few complications. No infectious complications and no acute urine retention were reported. Although it causes ulceration, as does rubber band ligation, no bleeding related to the procedure has been observed resulting in surgical treatment, the need for in-patient evaluation or repeated hemoglobin monitoring. There was no fecal incontinence before treatment, except minor soiling, and none until the end of the follow-up period. Only 9 patients (8.4%) reported external hemorrhoidal thrombosis, with no sex difference (P=0.603). The occurrence of thrombosis did not modify the duration of work stoppage (P=0.735) but had a negative impact on final satisfaction with a lower evaluation than without thrombosis (+3/5 vs. +4/5, P=0.030). No long-term complication was reported.
Energy use data
The average energy delivered during the procedure was 4,334±801 J (range, 2,450–7,000 J) with no relationship to the grade of preoperative prolapse (P=0.472). No correlation was observed between the intensity of energy delivered and the occurrence of postoperative external thrombosis (P=0.135) or immediate postoperative pain (P=0.716).
Results on prolapse and bleedings
Initially, 100 of 107 patients complained of grade 2 to 4 hemorrhoidal prolapse (preoperative grade 0–1, 7 patients; grade 2, 18; grade 3, 38; and grade 4, 44). After the average follow-up of 30 months, 30 were prolapse-free (30.0%). For the others, there was a significant evolution in prolapse (postoperative grade 0–1, 37 patients; grade 2, 36; grade 3, 26; and grade 4, 8) resulting in a significant decrease from a mean grade 3±1.06 to 2±1.23 (P<0.001) (Fig. 2). The results were not influenced by the energy intensity used (P=0.472).
Comparative evolution of intensity of the bleeding and of hemorrhoidal prolapse (P-value calculated for differences between pre- and postoperative evolution).
Before intervention, 102 patients (95.3%) reported bleeding. RFT had a significant positive effect (Fig. 2) leading to a highly significant overall decrease in bleeding intensity from 6/10±2.48 to 2/10±2.14 postoperatively (P<0.001). It allowed complete cessation in 53 patients. The remaining 49 patients had more bleeding preoperatively than those without postoperative bleeding (7/10±1.94 vs. 6/10±2.25; P<0.001). However, even in patients with persistent bleeding, improvement was largely significant, with intensity dropping to 3/10±2.12 (P<0.001) (Fig. 2).
The 11 patients operated on with aspirin (9 patients) or apixaban (2 patients), and all suffering from preoperative bleeding, had no more bleeding recurrence (P=0.221) and no heaviest postoperative bleeding (P=0.248) than patients without treatment. Like the others, they did not have immediate postoperative bleeding complications.
At baseline, 95 patients (88.8%) suffered from combined bleeding (7/10±2.07) and prolapse (mean grade 3±0.76). At the end of the study, 26.3% had no more symptoms (Fig. 2).
Results on quality of life
Concerning the main criterion of QoL evaluation, there was a good correlation between the anal discomfort perceived before and after the procedure and the evolution of the HEMO-FISSQoL score (preoperatively r=0.4; P<0.001 and postoperatively r=0.615; P<0.001). Anal discomfort related to the hemorrhoidal pathology diminished significantly from 7/10±2.19 to 2/10±2.41 (P<0.001) and the average QoL score decreased in a very significant way from 22±16.5 to 7/100±11.6 (P<0.001). Patients with initial grade 4 prolapse reported greater improvement in the final HEMO-FISS-QoL score (P=0.008).
All the patients noted an enhancement in their hemorrhoidal disease with a feeling of improvement and postoperative satisfaction both rated on average +4 out of 5. Patients with residual clinical prolapse still had a high level of satisfaction, on average +3/5±2.26, as did those with persistent bleeding (+3/5±2.45).
Finally, the acceptability of the technique appears to be excellent, with 91.6% of the patients wishing to be reoperated by radiofrequency if necessary and 96.3% advising it to their relatives. In patients without recurrence, these figures are respectively 96.4% and 98.8%. Even among patients who have experienced a recurrence, 73.9% would like to use the same procedure again and 86.9% would recommend it.
Recurrence survey and learning curve
During follow-up, 23 patients (21.5%) considered that they had a recurrence of their anal symptomatology, bleeding, or prolapse. They had a longer follow-up time on average than “non-recurrent” patients (37 months vs. 28 months, P=0.005). In multivariate analysis (sex, age, delivered energy, preoperative bleeding, prolapse, anal discomfort, or HEMO-FISS-QoL score), only high preoperative anal discomfort appeared as a potential predictor of recurrence (P=0.032). There was no more recurrence in patients with preoperative grade 4 hemorrhoidal prolapse than in patients with less prolapse (P=0.708). The average time to recurrence was 22.0±14.3 months (range, 2–52 months). However, among these 23 patients, only 6 required further surgical management (4 by Milligan-Morgan hemorrhoidectomy, 1 by DGHAL, and 1 by a new RFT), i.e. an overall reintervention rate of 5.6%. This reintervention took place on average 31±11.13 months (range, 15–43 months) after the first.
As hemorrhoidal RFT is a recent operative technique, with little experience, the patients were separated into 4 equal subgroups according to the date of intervention in order to investigate the existence of a possible learning curve. In order to avoid any chronological bias, the first group operated having a greater probability of recurrence compared to the more recently operated group and taking into account the time to relapse, the data were analyzed according to a Kaplan-Meier survival curve. No significant difference was found between each patient quartile for time to recurrence (Fig. 3), bleeding or prolapse.
Chronologically sequenced recurrence curves following 4 periods of intervention (from April 2016 to December 2020).
DISCUSSION
This study is the follow-up to the first French study conducted in 2018 on this new technique [20], extending the initial 2-year follow-up to 5 years and including 3 times more patients. The goals of this study were to assess the efficacy and safety of the Rafaelo procedure on hemorrhoidal symptoms and their maintenance in time and evaluate the rate of recurrence.
Its main limitation is its monocentric and retrospective nature. Limitations also include possible recall bias and the absence of a control group and there is a clear need to confirm the very hopeful results of this pilot study with further prospective randomized, controlled, multicenter trials. However, various parameters temper these limitations. Radiofrequency hemorrhoidal treatment, excepting Ligasure (Medtronic, Dublin, Ireland) and harmonic scalpels that are nonconservative surgical techniques, has been poorly studied; therefore, this study started from limited data. At the end of the study in September 2021, the literature review of published studies using PubMed Central (keywords: “radiofrequency and hemorrhoids,” “RFITT,” “Rafaelo procedure,” “radiofrequency thermocoagulation” except Ligasure) showed publications from only 8 different centers (1 in India [26], Czech [27], Germany [28], and Russia [29] and 2 in the United Kingdom [30, 31] and France [20, 32]). There are no publications comparing RFT following Rafaelo procedure with other surgical techniques, but one with DGHAL and RFT combined [29]. The use of radiofrequency in the treatment of hemorrhoidal disease was already studied in 2002 but by applying a ball electrode on the surface of the hemorrhoids [26] and that was the most published technique as noticed in National Institute for Health and Care Excellence guidance for radiofrequency treatment for hemorrhoids [33]. The Rafaelo technique used in this study is radically different by introducing an electrode directly into the internal hemorrhoidal pack. Duben et al. [34] described its pilot experience from 2007 to 2017 over 217 patients but with a 35% participation rate at 4 years [35], with other studies including only 74 patients with a 3-month follow-up [32], 70 patients at 6 months [28], 42 patients for 12 months [31], 27 patients for 20 months [30], or 73 patients for 24 months [36]. Thus, the strengths of the presented study are the description of the largest case series reported in France, one of the largest numbers of cases worldwide published and a high and satisfactory level of participation for a 5-year retrospective study, at 86.3%. The descriptive data of the study population are similar to other studies on the subject with a sex ratio of approximately 2/3 male and an average age of the 5th decade suggesting the absence of inclusion bias. The follow-up of more than 62 months for the first patients and an average follow-up of more than 30 months are very significantly the longest published to date with this technique in France. The results are consistent with those of the prospective studies performed [30, 31], including the use of analgesics [30, 31, 36]. Finally, reproducible and validated clinical symptom assessment tools were used, including a validated “proctological symptom scale” [22] and the HEMO-FISS-QoL score [23]. The primary endpoint, QoL estimated from this HEMO-FISS-QoL score, correlated well with the reported hemorrhoidal discomfort, attesting to the proper use of this questionnaire and its correct reflection of the QoL experienced by the patient and confirming the effectiveness of the telephone interview, which could have been questioned.
This new study, with 3 times as many patients, complements the previous one [20]. Despite a doubling of the average survey from 15 to 30 months, and up to 62 months, the overall patient’s satisfaction rate remained unchanged at +4/5 and the improvement of the HEMO-FISS-QoL score was confirmed. The felt anal discomfort decreased significantly in the same way, going in both observations from 7/10 preoperatively to 2/10 postoperatively. The results on the evolution of bleeding are globally comparable, decreasing from 7/10 to 1/10 in the first study and from 6/10 to 2/10 in the second one. The efficacy on prolapse remained the same, going on average from grade 3 to grade 2. This new study confirms the generally painless nature of RFT with better results than those found in the previous one (66.4% of the patients requiring at most only stage I painkillers vs. 51.3%) [20]. Acceptability was even better with time since the wish to be reoperated if necessary by the same technique went from 84.6% to 91.6% and the rate of recommendation from 89.7% to 96.3%.
Data analysis demonstrates the feasibility of outpatient RFT and its effectiveness on improving bleeding, hemorrhoidal prolapse, and QoL. Bleeding and prolapse disappeared completely in only 52.0% and 30.0% of patients, respectively. Moreover, for patients who still have bleeding, it becomes minor. In view of these results, one may wonder whether the preferred indication for RFT would not be the treatment of hemorrhage rather than that of prolapse but the results obtained do not allow this to be the case. Indeed, there is no more recurrence with grade 4 prolapse and the mean reduction of the hemorrhoidal prolapse from grade 3 to grade 2 leads to a significant improvement in QoL without the need for manual reintroduction. In addition, patients with the highest degree of prolapse experienced the greatest improvement in their QoL, as measured by the HEMO-FISS-QoL score, which should not exclude them from this new therapeutic procedure. Although the results are neither anatomically radical nor functionally perfect, the improvement in patient well-being can be major and leads to excellent acceptability of the technique as shown by the high recommendation scores. Since the introduction of the Longo procedure in 1998, all technical innovations have tended toward a less aggressive treatment of hemorrhoidal disease. RFT pursues this goal without the need for postoperative care while offering the possibility of a quick return to activity with an average of only 3 days off work (and none in 71.0% of patients), thanks to an easily controlled postoperative pain.
The absence of major complications, with only mild external thromboses and no long-term reported complications, makes this a safe process. This is very encouraging and a big difference when compared to Longo hemorrhoidopexy and its potentially serious complications [37-39]. In this study, the Rafaelo procedure was modified without the use of anoscopy in order to facilitate access to the hemorrhoidal packs with their exteriorization at the anal margin. This may explain the absence of anal fissure observed elsewhere among postoperative complications [32, 34].
Although the small number of patients under anticoagulant or antiaggregant treatment does not allow drawing definitive conclusions about the use of RFT in this particular situation and recommending performing it on anticoagulants, we can note that it has been used without significant complications in these patients.
Unlike other minimally invasive techniques, including DGHAL [40] or hemorrhoidopexy [41], there is no improvement with the acquired experience as shown by the study of the 4 time-ordered periods with Kaplan-Meier survival curve with the encouraging results remaining stable throughout the study. This may suggest the absence of a learning curve for senior proctologists. The use of the “externalized” procedure described for the first time in this trial may be one of the elements that facilitate its learning. This is in favor of an effective, reproducible, simple procedure, and therefore accessible to the greatest number of colorectal surgeons.
The tissue fibrosis induced by RFT results in tissue retraction and decrease in hemorrhoidal vascularization, which allows significant reduction or disappearance of prolapse [42] even in patients initially grade 3 or 4. Four internal hemorrhoidal bundles were systematically treated, with an average intensity of 1,084 J per pack. This investigation shows no correlation between power and reduction of hemorrhoidal prolapse but better estimating the optimal power with a specific trial could perhaps increase effectiveness on prolapse.
Moreover, RFT seems to maintain its efficacy over time for 78.5% of patients, resulting in a recurrence rate of 21.5% at 5 years that is broadly similar to that of DGHAL [39, 43-46], and only 5.6% of patients undergoing reoperation, half that of another publication [31], more than 31 months after the initial procedure. These results are sustained in April 2022, 72 months after the first intervention.
While it was feared that this minimally invasive technique could have resulted in “no pain, no gain,” the positive results of this study confirm the interest in radiofrequency in the management of internal hemorrhoidal disease. It defines the place of this new tool, less aggressive for the patients and respectful of their aspirations of a clear functional and of QoL improvement with a simple and fast postoperative recovery, allowing light and effective ambulatory management with “no pain but a gain.”
Of course, these results encourage further use but also the longer-term study of the hemorrhoidal RFT to define its optimal indications and its comparison with other more widely used procedures.
Notes
CONFLICT OF INTEREST
No potential conflict of interest relevant to this article was reported.
FUNDING
None.