{"paper_id":"262ae8a8-5d34-4280-89dc-a9823fdb4343","body_text":"ORIGINAL ARTICLE\nDoes Helica treatment of early endometriosis confer\nshort- and long-term benefits in terms of pain relief\nand sub-fertility?\nJill Adamson & Janani Iyer & Shamma Al-Inizi\nReceived: 30 January 2013 / Accepted: 11 June 2013 / Published online: 13 July 2013\n# Springer-V erlag Berlin Heidelberg 2013\nAbstract Early-stage endometriosis is a known contributing\nfactor for chronic pelvic pain and sub-fertility. To determine\nwhether Helica Thermal Coagulation is an effective short- and\nlong-term treatment for endometriosis-associated chronic pel-\nvic pain and sub-fertility. Thirty six patients were followed up\nfrom 6 weeks to 1 year post-Helica treatment of early endome-\ntriosis. Pain relief was assessed subjectively. Eight of the wom-\nen suffered from sub-fertility in addition to pelvic pain, while\nthree patients suffered from sub-fertility alone. Ninety-three\npercent were pain free at 6 weeks, 75 % were pain free at\n6 months and 37.5 % remained pain free at 1-year follow-up.\nOf those who continued to have pain at 1-year follow-up, three\nhad repeated Helica treatment, two had hysterectomy and\nbilateral salpingoopherectomy, and the rest were commenced\non different hormonal treatment to control endometriosis. Ten\nwomen (62 %) conceived within 1 year of treatment. Helica\ncoagulation seems to be an effective way of treating early\nendometriosis-associated pelvic pain and sub-fertility. Howev-\ner, its effects only seem to be short term, with a decline in\nsymptom relief and pregnancy rate over the 12-month post-\noperative period. Larger RCT are required.\nKeywords Endometriosis . Helica Thermal Coagulation .\nSub-fertility\nIntroduction\nEndometriosis is one of the most common gynaecological\nconditions. It is defined as the presence of endometrial-like\ntissue outside the uterus, which induces a chronic, inflamma-\ntory reaction [ 1]. The most commonly affected areas are the\npelvic organs and peritoneum. The exact pathophysiology of\nendometriosis remains uncertain. However, the most accepted\ntheory is that of retrograde menstruation [2].\nThe condition is predominantly found in women of repro-\nductive age, from all ethnic and social groups. Symptoms\ninclude severe dysmenorrhoea, deep dyspareunia, chronic\npelvic pain, ovulation pain, infertility and dyschezia. Many\nare in fact asymptomatic, making the diagnosis of endome-\ntriosis rather difficult and can only be confirmed by visual-\nisation, for example, at laparoscopy, which is the gold stan-\ndard for diagnosing the disease [ 1].\nThe prevalence in the female population is difficult to\nmeasure as so many women go undiagnosed or misdiagnosed;\nhowever, it is estimated to be approximately 10 % [ 3].\nNowadays, it is generally accepted that there is a strong\nlink between endometriosis and infertility. Studies have\nshown endometriosis to have a prevalence of 0.5 % –5%i n\nfertile women compared with a much higher prevalence of\n25 %–40 % in infertile women [4]. Although the exact nature\nof this link is not yet fully understood, it is suggested there is a\nmulti-factorial element to it [5], for example, altered hormonal\nand cell-mediated function, ovulatory and peritoneal fluid\nabnormality, anatomical disorders, poor embryo quality and\nimpairment of implantation [5–7].\nTreatment of endometriosis can be either medical or surgi-\ncal. While medical treatment such as 6 months of GnRH\nanalogues provides most with symptom relief, long-term\nfollow-up studies show a high recurrence rate [ 8, 9]. Laparo-\nscopic surgery has allowed us to use this minimally invasive\ntechnique not only to diagnose but also to treat endometriosis\nby excision or ablation of the lesions using laser, monopolar or\nbipolar diathermy. Despite these developments, the optimal\ntherapy for endometriosis-associated pelvic pain has yet to be\nestablished [10].\nThe Helica Thermal Coagulator is a relatively new treat-\nment method used for endometriosis. It is produced by a\nBritish company based in Edinburgh, which was founded by\nJ. Adamson ( *) : J. Iyer : S. Al-Inizi\nDepartment of Obstetrics and Gynaecology,\nSouth Tyneside Hospital, South Shields, UK\ne-mail: j.l.adamson@hotmail.co.uk\nGynecol Surg (2013) 10:213 –217\nDOI 10.1007/s10397-013-0803-7\n\nMr Maurice M. Howieson in 1993. It uses a combination of\nlow-level electrical power (2–8 W) combined with helium gas,\nwhich produces a beam that causes coagulation and\nhaemostasis to endometrial tissue [ 11, 12]. While destroying\nthe endometrial tissue, it also destroys the nerve endings,\nallowing immediate pain relief. It has been shown to be a safer,\ncheaper and more effective method of treatment of endometri-\nosis compared with medical treatment [13].\nAims and objectives\nWhile there are studies confirming the short-term benefits of\nthe effectiveness of Helica Thermal Coagulator (TC) in the\ntreatment of minimal to mild endometriosis-associated pain\nand infertility, there are no studies looking at the longer term\nbenefits. The aim of our study was to look at the long-term\neffects of Helica TC on minimal to mild endometriosis-\nassociated pain and infertility.\nMethod\nThis was a prospective observational study carried out between\nOct 2009 and April 2012. A total of 36 patients were included in\nthe study. Criteria for inclusion in the study were a confirmed\ndiagnosis of stage 1 or 2 endometriosis at laparoscopy according\nto the American Fertility Classification [14] with one or more of\nthe following symptoms: dysmenorrhoea, dyspareunia or sub-\nfertility. No treatment for endometriosis had been given at least\n6 months prior to their Helica TC treatment.\nTheir ages ranged from 17 to 50 years, with a mean age of\n32 years. Of the 36 patients, 25 patients complained of pain\nonly, 8 complained of both pain and sub-fertility and 3\ncomplained of sub-fertility alone.\nOf those patients complaining of sub-fertility, three\n(27 %) suffered from primary sub-fertility and eight (73 %)\nsuffered from secondary sub-fertility.\nAll patients were seen in clinic by a gynaecologist, and a\nfull history and examination were performed. Informed con-\nsent was then taken, including an explanation of the risks of\nlaparoscopy and Helica TC.\nAll procedures were performed as a day case. Laparoscopy\nwas performed by the same surgeon, and staging of the endo-\nmetriosis was done according to the American Fertility Society\nrevised classification of endometriosis [ 14]. The lesions of\nendometriosis were seen mostly in Pouch of Douglas, vesico-\nuterine pouch, ovaries and pelvic peritoneum. Most of the\nlesions were black and red endometriosis. There were no cases\nwith pelvic adhesions and endometriomas included in the\nstudy as only early (grades I and II) cases were included. There\nwas no correlation between the pain symptoms and location of\nlesions. There was no histological confirmation of\nendometriosis, and diagnosis was made by visualisation of\nendometriotic implants laparoscopically. The Helica TC was\nused to treat all visible spots of endometriosis. The probe is\nplaced 3–4 mm from the target, and fulguration occurs after\nfew seconds of treatment. Following the procedure, suction\nirrigation of the peritoneal cavity was done, and approximately\n300 ml of Hartmann’s solution was instilled to prevent future\nintra-peritoneal adhesions. Patients were not prescribed with\nany medical treatment for endometriosis following the\nprocedure.\nPatients were followed up prospectively for pain relief and\npregnancy in the gynaecology outpatient clinics at 6 weeks,\n6 months and a year post-Helica TC treatment. On review, they\nwere asked to rate their pain relief as no change, satisfactory\nrelief or pain free. Confirmation of pregnancy was done by\nearly sonographic identification of an intrauterine gestation sac\nwith fetal pole and fetal heartbeat. Routine antenatal care was\nprovided, and patients were followed up until delivery.\nResults\nTwo patients were excluded as they were lost to follow-up\nimmediately after their laparoscopic Helica TC treatment. A\nfurther three patients were excluded as another cause for\ntheir chronic pelvic pain was found during the year post-\nHelica TC treatment, two were gastroenterology related, and\none was orthopaedic related. Therefore, a total of 31 patients\nwere included in the study results.\nFigure 1 shows the percentage of pain relief according to\nthe duration of post-Helica treatment.\nOf the 31 patients who were followed up post-operatively,\n20 patients complained of pain only, 8 complained of both\npain and sub-fertility, and 3 complained of sub-fertility alone.\nOf the 28 patients who complained of chronic pelvic pain,\nat their 6-week follow-up, 2 patients (7 %) had no change in\ntheir pelvic pain and 26 (93 %) were either satisfied or\ncompletely pain free. At their 6-month follow-up, four pa-\ntients were excluded as they were pregnant and could not put\nthe relief of their pain down to the Helica TC treatment alone.\nTherefore, of the 24 patients remaining, 18 (75 %) were\nsatisfied or pain free. At their 1-year follow-up, a further five\npatients were excluded due to pregnancy, one was excluded as\nshe was started on the combined contraceptive pill due to\nunmanageable pelvic pain, and a further two were excluded\nafter starting on GnRH analogues following their 6-month\nappointment for the same reason. Of the 16 patients remaining,\nonly 37.5 % were pain free or satisfied with their pain relief.\nFigure 2 shows the time period post-operatively at which\nthe pain of patients who had initially seen an improvement in\ntheir symptoms recurred.\nOf those patients who had recurrence of their pain at their 1-\nyear follow-up, two had a hysterectomy and bilateral salpingo-\n214 Gynecol Surg (2013) 10:213 –217\n\noophorectomy, three had repeated Helica TC treatment, one had\nZoladex, and one started on the combined contraceptive pill.\nOf the 11 sub-fertility pat ients, five became pregnant\nwithin a year following Helica TC treatment, giving a cumu-\nlative pregnancy rate of 45 % over the year.\nDuring the 1-year follow-up of these patients post-Helica\nTC, there were a further five pregnancies in patients who\nhad not complained of sub-fertility initially. This gives a\ntotal of ten pregnancies in women up to a year post-\nHelica TC treatment, giving a 62 % cumulative pregnan-\ncy rate over the year. Seven patients became pregnant\nwith no ovulation induction medication, and three pa-\ntients conceived while taking ovulation induction medi-\ncation. Eight pregnancies were ongoing and went to\nterm; unfortunately, two of the pregnancies ended in\nearly miscarriage.\nFigure 3 shows that there is a steady pregnancy rate over\nthe 1 year post-Helica TC treatment.\nDiscussion\nThe treatment of choice for minimal/mild endometriosis-\nassociated chronic pelvic pain and infertility remains a wide-\nly debated topic. Endometriosis is a recurrent disease, which\nmakes the treatment of it rather challenging, and the majority\nof women are not going to improve if left untreated [ 15, 16].\nMedical treatment for endometriosis-associated pelvic\npain is associated with a high recurrence rate as well as\nside effects, compared to surgical excision or ablation\n[15, 17–19]. However, the optimal method for surgical\ndestruction of endometriotic implants remains the sub-\nject of ongoing debate [ 20, 21].\nOur study has shown Helica TC to be an effective treat-\nment of minimal to mild endometriosis-associated pelvic\npain with a 93 % improvement in pain relief 6 weeks post-\noperatively. However, it seems that the benefits are only\nshort term with only 75 % improvement rate 6 months\npost-operatively and 37.5 % improvement 1 year post-\noperatively. Other studies have found a good improvement\nrate in pain relief up to 6 months post-operatively, but no\nother studies have looked at the longer term effect of Helica\nTC. Al-Inizi et al. reported 72 % improvement in pain 6-\nmonths post-operatively [ 7]. Nardo et al. found a 74.4 %\nimprovement in pain relief 3 months post-operatively and\n87.4 % improvement 6 months post-operatively [ 12].\nThe possible reason behind the high recurrence rate of\npain related to endometriosis post-Helica treatment could be\nFig. 2 Graph to show time period at which the patients ’ pain recurred\npost-operatively\nFig. 1 Graph to show the percentage of patients with pain free or\nsatisfactory pain relief following Helica TC\nFig. 3 Graph to show the number of pregnancies up to 12 months post-\nHelica TC\nGynecol Surg (2013) 10:213 –217 215\n\nrelated to the superficial effect of this procedure on the\nendometriotic implants resulting in the incomplete treatment\nof the implants and recurrence of symptoms.\nThe management of endometriosis-associated infertility is\ndifficult. Treatment choices include conservative manage-\nment, medical treatment such as GNRH analogues, OCP\nand Danazol, and conservative surgical therapy as well as\nassisted reproductive technologies. Hull et al. reported a\n55 % cumulative pregnancy rate at 30 months after expectant\nmanagement [ 22]. A comprehensive review in 2007 exam-\nining 24 randomised controlled trials concluded that preg-\nnancy outcomes did not improve from treatment with ovu-\nlation suppression agents compared to placebo [ 23]. The\ndrugs merely delay fertility. In accordance with the review\nfindings, the ESHRE guideline 2005 [ 24] for the diagnosis\nand treatment of endometriosis does not recommend the\nsuppression of ovarian function alone to improve fertility.\nIt also indicates that ablation of endometriotic lesions plus\nadhesiolysis to improve fertility in minimal to mild endome-\ntriosis is beneficial compared to diagnostic laparoscopy\nalone [24, 25]. A large Canadian randomised controlled trial\nfound a cumulative pregnancy rate of 30.7 % up to 36 weeks\npost-operatively following laparoscopic surgical treatment,\ncompared with 17.7 % in the control group who had just a\ndiagnostic laparoscopy [ 26].\nWhile it is well reported that laparoscopic surgical man-\nagement of endometriosis-associated infertility is superior to\nmedical treatment [26], the optimum method of laparoscopic\ntreatment however remains an ongoing source of controver-\nsy with technology advancing as new devices are developed.\nA number of studies have shown the effectiveness of Helica\nTC in treating minimal to mild endometriosis-associated infer-\ntility. Nardo et al. found a 23.2 % cumulative pregnancy rate\nover a year post-Helica TC treatment [11]. After this, Al-inizi\net al. found a 34 % cumulative pregnancy rate up to 6 months\npost-operatively [7]. Our study gives an even higher cumula-\ntive pregnancy rate of 62 % a year post-operatively.\nHelica TC has been shown to be a safe, cost-effective and\nsuccessful way of treating endometriosis-associated pelvic\npain laparoscopically [ 13, 27]. Unlike laser therapy or elec-\ntrosurgery, the Helica TC minimises tissue ischaemia, char-\nring and desiccation, which are potential causes of adhesions\nand persistent pelvic pain and infertility [ 11, 12, 28]. Helica\nTC may have a more rapid healing rate due to its limited depth\nof penetration and ability to precisely dissect adhesions as well\nas their reduced recurrence rate. Pelvic adhesions can impair\noocyte release from the ovary and inhibit ovum pick up or\ntransport [29]. The Helica TC can be performed at the time of\ndiagnosis at laparoscopy, and as shown in our study, the\npregnancy rate is highest in 2 –6 months post-treatment.\nHelica TC will treat the active visible endometriotic le-\nsions. However, non-pigmented lesions or deep lesions will\nbe missed. This may account for the failure rate of 7 % in\nterms of pelvic pain relief initially at 6-week follow-up in our\nstudy [30–32].\nConclusion\nHelica TC seems to be a safe, cheap and effective short-term\nsurgical treatment for women suffering with minimal to mild\nendometriosis-associated pelvic pain and infertility. However,\nits effects seem to decline after 12 months post-operatively. It\ntherefore appears that Helica TC is an effective short-term\ntreatment for chronic pelvic pain associated with minimal to\nmild endometriosis, and patients need to be aware of this\npossible short-term benefit. The recurrence of symptoms can\nbe due to the superficial effect of Helica on the endometriotic\nimplants resulting in possible incomplete treatment.\nWith a cumulative pregnancy rate of 45 % up to 1 year\npost-Helica TC, this study would suggest that performing a\ndiagnostic laparoscopy and Helica TC is by far an optimal\ntreatment choice for sub-fertility, compared with medical\ntreatment where chances of conceiving are delayed whilst\novulation is suppressed.\nThe benefits of Helica TC compared with other conservative\nlaparoscopic approaches such as laser and electrocoagulation,\nmedical and expectant management have not been looked at in\nthis study. Larger randomised controlled trials need to be car-\nried out to confirm the advantages of Helica TC found in this\nstudy and others, and to compare Helica TC with other tools\nsuch as bipolar cautery and laser treatment.\nReferences\n1. The Royal College of Obstetricians and Gynaecologists. 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