International Journal of Surgery

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1 International Journal of Surgery 7 (2009) Contents lists available at ScienceDirect International Journal of Surgery journal homepage: Radiowave ablation and mucopexy for prolapsing hemorrhoids A pilot study P.J. Gupta *, S. Kalaskar Fine Morning Hospital and Research Center, Gupta Nursing Home, Laxminagar, Nagpur , India article info abstract Article history: Received 25 January 2009 Received in revised form 3 March 2009 Accepted 24 March 2009 Available online 9 April 2009 Keywords: Hemorrhoids Radiowave Suture ligation Pain Ablation Objective: The author proposes a technique of radiowave ablation and mucopexy of hemorrhoids for patients having symptomatic and prolapsing hemorrhoids and enumerates the events in such patients over 10 years. Material and method: From May 1997 through December 2007, 3148 patients were included in the study. The hemorrhoids were ablated using radiowaves through a Ellman radiowave generator and were followed by suture ligation with absorbable suture material under vision. Operating time, postoperative complications, time to return to work, and outcome of the procedure were analyzed. Results: The mean procedure time was 8 0 min (range, 5 14 min). The mean total analgesic dose and duration of pain control using analgesics was 17 5 tablets, and 10 4 days respectively. The mean period of incapacity for work was 6 days [range 4 17 days]. Complications were identified in 4.8% patients. The postoperative follow-up after 4 weeks revealed therapeutic success in 3013 patients (95.7%), who presented with hemorrhoidal bleeding. Prolapse was no longer observed in 3085 (98%) of patients and 3022 (96%) patients experienced no pain after defecation. Up to December 2006, a total of 2897 patients were treated with this method patients responded to our inquiry conducted at the beginning of Ninety-six percent of these patients confirmed that they no longer experienced any bleeding or pain during defecation and ninety-two percent patients did not had any prolapse. Conclusions: This study shows that radiowave ablation followed by suture ligation of hemorrhoids is a simple, cost effective and convenient modality in treating prolapsing hemorrhoids. Ó 2009 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. 1. Introduction Hemorrhoids occur in up to 80% of the population, involving any age and affecting both males and females equally. 1 Symptoms of hemorrhoids include bleeding, mucosal or fecal soiling, itching and, occasionally, pain, which, if left untreated, continue to cause physical and social problems to patients. Numerous modalities and techniques have been developed to treat symptomatic hemorrhoids. First and second-degree hemorrhoids can be treated conveniently on an outpatient basis by means of sclerotherapy, photocoagulation, cryotherapy and rubber band ligation, while severe prolapsed or circumferential hemorrhoids can be treated using the various types of hemorrhoidectomy procedures. 2 In recent years there has been a better understanding of the pathophysiology of hemorrhoids. Current knowledge accepts that hemorrhoids originate in the normal anal fibro-musculo-vascular cushions, which are three in number and are present by birth and * Corresponding author. Tel.: þ ; fax: þ addresses: drpjg@yahoo.co.in, drpjg_ngp@sancharnet.in (P.J. Gupta). play a complementary role in fecal continence by varying their size. It is when the submucosal attachment fibers break down, that the anal cushions lose their control to get enlarged and slide out of the anal canal to cause the classical symptoms of mucosal prolapse and anal bleeding. In addition, an increased flow of arterial blood directly into the venous bed through arteriovenous shunts, enhanced by sphincter spasm and elongation with kinking of the hemorrhoidal vessels, which is caused by prolapsing mucosa, seems to play some role. 3 In short, symptomatic hemorrhoids consist of degenerative connective tissue and vessels and are generally known as the outward manifestation of a downward displacement of the anal cushions. 4 On the basis of these new concepts, Longo s stapled technique for hemorrhoidopexy and the Doppler-guided hemorrhoidal artery ligation technique have been developed. Stapled hemorrhoidectomy aims at restoring the normal relationship between anal mucosa and sphincters by excision of the prolapse. In randomized trials, stapled hemorrhoidectomy has shown a greater reduction of postoperative pain, a greater reduction in hospital stay, and an earlier return to normal activity than excision hemorrhoidectomy which is further modified by using newer instruments like ligasure and harmonic /$ see front matter Ó 2009 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. doi: /j.ijsu

2 224 P.J. Gupta, S. Kalaskar / International Journal of Surgery 7 (2009) scalpel. 5 Nevertheless, this technique requires appropriate training to avoid possible severe complications (persistent postoperative pain, pelvic and retroperitoneal sepsis, rectal perforation, and rectovaginal and urethral fistulas) and is reported to have higher incidences of recurrence. Doppler-guided ligation of the hemorrhoidal artery is a safe and effective alternative to hemorrhoidectomy and is associated with minimal discomfort and low risk of complications. 6 However, its efficacy in controlling large prolapsing hemorrhoids and long-term results are debated. A simpler technique for the reduction of the size of the hemorrhoids with control of bleeding and prolapse is the ligation of hemorrhoids under vision. This technique is based on the fact that the hemorrhoidal vessels have a constant anatomical location. Usually, they penetrate the hemorrhoid pile in the base. 7 A stitch that is put on the base of the hemorrhoid cushion is able to diminish significantly the blood flow to the hemorrhoidal plexus. Thus, the consecutive ligation in this manner, of all the visual hemorrhoidal cushions arrests the bleeding and controls prolapse as well. This procedure of ligation of hemorrhoidal cushion has a long history and is termed with various nomenclatures like pile suture, 8 obliterative suture technique, 9 ligation and anopexy 10 and ligation under vision, 11 etc. We modified this technique by exposing the hemorrhoids to radiowaves before their suture ligation. Radiowave ablation is a technique that results in immediate reduction of blood flow of the tissue under focus of these waves and induces healing by way of cicatrisation. 12 These waves ablate the tissue by converting radiowaves into heat. The alternating current passes down from an uninsulated electrode tip to the targeted tissues and generates changes in the direction of ions within the tissue fluid. This creates ionic agitation and frictional heating. This process drives out the extra- and intracellular water from the tissue, and ultimately destroys the tissue by coagulative necrosis. The result of this ablation is fibrosis and fixation of the ablated tissues. 13 We attempted to blend the best of the above two methods 14 to achieve a synergic effect. The ablation was carried out using the radiowaves and thereafter the hemorrhoids were suture ligated. This retrospective study describes the surgical procedure and assesses its benefits in terms of surgical outcome, ease of surgical maneuver, and postoperative pain in a relatively large patient cohort. This report also evaluates the results of this procedure over the past ten years in the treatment of prolapsing hemorrhoidal disease. 2. Materials and methods Patients having symptomatic and prolapsing hemorrhoids (Grade II IV) attending the outpatient clinic were included in this study. Exclusion criteria were acutely thrombosed piles or concurrent anal pathology (e.g., fistula, fissures, etc). Patients suffering from Grade II hemorrhoids were considered suitable for surgery because of the severity of symptoms (i.e., profuse bleeding) despite previous conventional less invasive treatments, and also were scheduled for surgery at their own specific request. An informed consent was taken from all the patients. This study was approved by the hospital ethics committee. The patients underwent a complete medical history with emphasis on hemorrhoidal symptoms, previous conservative or surgical treatment, and other anorectal conditions. Clinical examination, anoscopy, rigid rectoscopy were performed in all the patients to accurately stage the disease and colonoscopy was performed in addition, to rule out other colorectal conditions in every patient older than 50 years. The four outcome measures were symptomatic recurrence, post-procedure pain, incidence of complications, and patient satisfaction after at least 12-month post-procedure. Surgical procedure. The procedure was performed either under local, spinal or short-term general anesthesia as per the decision of the anesthesiologist. With the patient in a lithotomy position, the three skin tags corresponding to three principle sites of hemorrhoidal cushions, namely 3, 7 and 11 0 O clock position were held with artery forceps and retracted out to visualize the hemorrhoids. The exposed hemorrhoids were ablated using radiowaves. A Ellman Dual Frequency 4 MHz radiowave generator [Ellman International Oceanside, New York] was used for ablation of hemorrhoids. The unit is provided with a handle to which different electrodes could be attached to meet the requirements of the procedure. A ball electrode meant for coagulation was used in this procedure. Beginning at the pedicle, the complete hemorrhoidal mass was evenly coagulated by gradually rotating the ball electrode. The output power intensity of the radiowave generator was so adjusted as to produce shrinkage of the tissues without creating a char. The gradual change of hemorrhoids to dusky white color (blanching) indicated satisfactory ablation. Care was taken to avoid charring of rectal mucosa or the anoderm by meticulously targeting the hemorrhoids mass [Fig. 1]. This was followed by suture ligation of the hemorrhoidal cushions using a half-circle 45 mm round needle and absorbable 1-0 chromic catgut (No Ethicon UK). Firstly, a transfixing suture was applied at the hemorrhoidal pedicle. A new suturing began distally 5 mm below the dentate line in a continuous locking manner and included the mucosa, submucosa and half the depth of the anal sphincter muscles to reach up to the pedicle. The ligations were performed proximal to the dentate line in a relatively insensitive region [Fig. 2]. Any secondary hemorrhoids found were also treated on the same line as the primary hemorrhoids. The patients were assessed after 8 h of the procedure and were discharged if they were found comfortable with regard to pain and reporting no difficulty in passing urine. All the patients were prescribed with a combination of Tramadol Hydrochloride and Paracetamol for post-procedure analgesia. They were instructed to take these tablets as and when required and to attend the casualty department in case the pain exceeds tolerance level or experiencing any significant complications, especially any spontaneous bleeding or perianal sepsis. Domiciliary treatment suggested was a high-residue diet, stool softeners, and immediate warm sitz baths. Postoperatively, pain was assessed using a 10-cm linear analog scale in which 0 corresponds to no pain and 10 to maximum pain. Patients were asked to score their pain in the morning for the first 2 weeks and also to record the use of analgesics everyday for the first 14 days. Our advice was to return to work and normal daily Fig. 1. Hemorrhoidal ablation using radiowaves.

3 P.J. Gupta, S. Kalaskar / International Journal of Surgery 7 (2009) Table 1 Complications after ligation and mucopexy of hemorrhoids [Total number of patients 3148]. Complications Number of patients (percent) Perianal thrombosis 68 (2.1%) Bleeding needing readmission 11 (0.3%) Pain needing readmission 5 (0.1%) Urinary retention 32 (1.01%) Pruritus ani 13 (0.4%) Mucosal narrowing 10 (0.4%) Wound Sepsis 9 (0.3%) activities as soon as they felt able to do so. Pain assessments focused on the amount of pain experienced immediately, 24 h, 7, 14 and 30 days following the procedure. Patients were also required to disclose the total number of analgesic tablets consumed during the month after the procedures. Patient monitoring included a series of clinical examinations by the surgeon: prior to the operation, then after 4 weeks, and finally after a minimum of 12 months. The patients were asked to report anytime afterward if they have any complaints. An independent observer assessed patient satisfaction rate in the absence of the operating surgeon at the 12- month follow-up visits using a 10-point scale (1 ¼ extremely dissatisfied, 10 ¼ very satisfied). 3. Results Fig. 2. Hemorrhoids after radiowave ablation and mucopexy. From May 1997 through December 2007, 3148 patients were treated by this technique in our hospital. The group consisted of 1980 male patients and 1168 females (age years). Main symptoms presented were bleeding and prolapsing hemorrhoids. The median duration of symptoms was 2.7 years. The procedure was performed in 292 patients with grade II, 2657 patients with grade III and 199 patients with grade IV hemorrhoids. The mean admission period was 9.7 h (range 8 22 h). On average, 3.04 hemorrhoids were suture ligated per patient. The mean procedure time which included both, radiowave ablation and mucopexy, was 8 0 min (range, 5 14 min). The mean total analgesic dose and duration of pain control using analgesics was 17 5 tablets, and 10 4 days respectively. Complications were identified in 4.8% patients, which included retention of urine; pain needing readmission, bleeding needing readmission, external hemorrhoidal thrombosis, mucosal narrowing, sepsis and pruritus [Table 1]. The postoperative follow-up after 4 weeks revealed therapeutic success in 3013 patients (95.7%), who presented with hemorrhoidal bleeding. Prolapse was no longer observed in 3085 (98%) of patients and 3022 (96%) patients experienced no pain after defecation. 92% patients completed the one-year follow-up and 89 percent of them were asymptomatic. Up to December 2006, a total of 2897 patients were treated with this method patients responded to our inquiry conducted at the beginning of Ninety-six percent of these patients confirmed that they no longer experienced any bleeding or pain during defecation and ninety-two percent patients did not had any prolapse. On rectal examination of the remaining 8% of patients complaining of prolapse, it was found that five percent of them had residual skin tags which they were considering as prolapse. They were reassured about the benign nature of these tags. The patients complaining of intermittent bleeding were treated conservatively with flavonoid derivatives, stool softeners and dietary modification. Those not responding to these measures were treated with band ligation or infrared coagulation. Those complaining of prolapse were offered a redo procedure. Thirty-two patients complained of continence disturbances. As a preoperative anal sphincter function assessment was not conducted, we were unable to know whether this anal sphincter dysfunction was already present preoperatively and if the symptoms of incontinence were compensated for by the prolapsing hemorrhoids, as we do not see its direct relation to the procedure as such. The mean patient satisfaction score (1 ¼ extremely dissatisfied, 10 ¼ very satisfied) was 8.3 on visual analogue scale. 4. Discussion The concern regarding the management of postoperative pain, need for long-term wound care and fear of complications following hemorrhoidectomy had prompted the surgeons to modify surgical techniques using various innovative approaches. 15 Surgical or medical means to reduce sphincter muscle spasm, different types of analgesia and anesthesia and use of antibiotics to reduce pain have been tried. Despite these approaches, the primary cause of pain, the trauma to the pain sensitive perianal skin and anal sphincters during excision of hemorrhoids still persists and reduction in pain is usually limited. 16,17 Two techniques namely, stapled hemorrhoidectomy and Doppler-guided hemorrhoidal artery ligation are known to cause less post-treatment pain. Through a few controlled trials these techniques have come to be associated with less postoperative pain and an earlier return to normal activity. 18 However, in this era of cost containment, one has to justify such costlier alternatives if equally good results could be achieved using other simpler techniques. 19 The procedure of radiowave ablation and mucopexy can be termed as a minimally aggressive, as it does not involve any mucosal or anodermal excision and is very simple to perform as it follows a very basic surgical maneuver, i.e., suturing. Suture ligation has been previously performed as a single procedure and in combination with other surgical techniques for treating early and advanced grades of hemorrhoids. 20 Doppler-guided hemorrhoidal dearterialization is getting popular being less invasive as compared to conventional or stapled hemorrhoidectomy. However, as more cases of recurrence have been reported with this procedure in long term and especially in grade III hemorrhoids, the procedure is being modified by applying a running suture with three to five stitches which is termed as suture anopexy 21 mucopexy or recto-anal repair. 22 This running suture application is almost identical to our procedure of suture ligation, which does not needs an expensive Doppler-guided hemorrhoidal ligator.

4 226 P.J. Gupta, S. Kalaskar / International Journal of Surgery 7 (2009) The suture ligation of the hemorrhoidal pedicle and adjacent cushion efficiently enable obliteration of the hemorrhoidal vessels. The corpus cavernosum recti, constituting the hemorrhoidal pedicle, are located in the anorectal submucosa above the dentate line approximately 3 5 cm from the anal verge. The suture ligation procedure helps in prevention of mucosal prolapse and control of remnant hemorrhoids originating from the aberrant corpus cavernosum recti piercing the rectal wall. 23 It has been suggested that the source of remnant or secondary hemorrhoids is from the unobliterated vessels, which are present on the posterolateral position of the rectal wall. 24 Suture ligation ably takes care of these vessels too. As suture ligation is confined to the protruding hemorrhoids only and as it does not attempt any excision, it preserves the sensitive anoderm and the rectal mucosa. 25 Apart from fixing the prolapsing hemorrhoids to the underlying structure to prevent prolapse, the treatment should also be aimed at removal of the dilated submucus anal venous plexus and induce fibrosis of the hemorrhoidal tissue which will attach and draw in the hemorrhoidal cushion, obliterating the submucus space and eventually preventing recurrence of bleeding and relapse of the hemorrhoids. 26 The procedure of radiowave ablation precisely serves this purpose. 27,28 The radiowave device has an ability to accurately deliver specific amounts of radiofrequency energy at relatively low temperatures (38 70 C) to the target tissue, so that the heat dissipation and damage to adjacent tissue structures are minimized. 29 Limiting tissue desiccation spares surrounding mucosa and underlying muscle, thus reducing edema, pain, fibrosis and risk of hemorrhage. 30,31 As the fibrosis is minimum, the tissue flexibility is more or less preserved. 32 The goal of the treatment for hemorrhoidal disease is to reduce the blood supply to the hemorrhoidal plexus and fix the hemorrhoidal cushions to the underlying structures. The procedure of radiowave ablation followed by mucopexy achieves this goal. Radiowave ablation removes the dilated submucus anal venous plexus and fixes the anal mucosa to the underlying muscle to obliterate submucus space. 33 During the postoperative follow-ups, the treated hemorrhoids by our technique were found to be replaced by segmented scar firmly adhered to the underlying structures. As we have not assessed continence scores before or after the procedure, conclusion on the effects of this procedure on the sphincter function is difficult. It is however, accepted that there should be greater sphincter dysfunction with grade IV hemorrhoids when compared to grade II hemorrhoids. It can be speculated that as the procedure of hemorrhoidal ablation and mucopexy does not carry out any dissection or excision of the sphincter complex, the possibility of anal sphincter damage is less as compared to other procedures. In our opinion ablation and mucopexy of hemorrhoids is relatively painless, easily learned and is a minimally invasive therapeutic technique that offers a good alternatives to all other known treatments of symptomatic and prolapsing hemorrhoids in the sense that the complication and re-prolapse rates are comparable. To sum up, the above study shows that radiowave ablation and mucopexy of the hemorrhoids decreases vascular inflow and achieves fixation of the hemorrhoidal cushions. The complications are comparable with those associated with other methods and no complications of serious nature were encountered. 5. Conclusion Although, conclusions drawn from a retrospective analysis are of limited value, the data presented here provide enough evidence that a combined technique of radiowave ablation and mucopexy of hemorrhoids is quick to perform, easy to learn and bloodless in nature. It is economical for the patient in the sense that no expensive disposables are needed and the hospital stay is short. However, more randomized and comparative studies with the conventional techniques are nonetheless called for to assess the above findings. Conflict of interest The authors have no conflict of interest. Funding No funding involved. Ethical approval Ethical approval was sought from the hospital ethical committee. References 1. Chand M, Nash GF, Dabbas N. The management of haemorrhoids. Br J Hosp Med (Lond) 2008;69: Tamelis A, Latkauskas T, Pavalkis D, Saladinskas Z, Vagdys S. Evidence based treatment of hemorrhoids. Acta Chir Iugosl 2008;55: Sardinha TC, Corman ML. Hemorrhoids. Surg Clin North Am 2002;82: Haas PA, Fox Jr TA, Haas GP. The pathogenesis of hemorrhoids. Dis Colon Rectum 1984;27: Lacerda-Filho A, Silva RG. Stapled hemorrhoidectomy: present status. Arq Gastroenterol 2005;42: Wa1ega P, Scheyer M, Kenig J, Herman RM, Arnold S, Nowak M, et al. 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