{"paper_id":"2d6f0898-0702-4348-adb5-dbc9463294d2","body_text":"Manuscript accepted for publication\nProvisionally accepted for publication\nSYSTEMATIC REVIEW AND META-ANALYSIS\nAblation and risk of recurrence in endometrioma: a systematic review and meta-analysis\nCarlo Ronsini *, Irene Iavarone, Maria Giovanna Vastarella, Clorinda Vitale, Giada Andreoli, \nMarco Torella, Pasquale De Franciscis\nDepartment of Woman, Child and General and Specialized Surgery, University of Campania “Luigi\nVanvitelli”, Naples, Italy\n*C\norresponding author: Carlo Ronsini, M.D., Department of Woman, Child and General and \nSpecialized Surgery, University of Campania “Luigi Vanvitelli”, Naples, Italy.\nEmail: carlo.ronsini@unicampania.it \nDo\ni: 10.36129/jog.2025.216 \nABS\nTRACT \nObjective. Ovarian endometriosis, or endometriomas, is a common manifestation and is typically\ntreated via laparoscopic cystectomy. However, this method may compromise ovarian function.\nAblation, involving thermal destruction of endometriosis cells, is emerging as an alternative.\nDespite some evidence suggesting less impact on ovarian function, there is a lack of robust data \non the efficacy of ablation in preventing recurrence. This systematic review and meta-analysis aim\nto evaluate the recurrence rates of ablation compared to standard cystectomy for ovarian \nendometriomas.\nMaterials and Methods. This study followed PRISMA guidelines and was registered with\nPROSPERO (protocol number CRD549177). Comprehensive searches were conducted in \nPubMed, EMBASE, Scopus, Google Scholar, ClinicalTrials.gov, and the Cochrane Central Register\nup to May 2024. Inclusion criteria focused on studies involving patients with at least one ovarian \nendometrioma treated with ablation or cystectomy, reporting recurrence rates, and having a\nminimum follow-up of 12 months. The studies were assessed for quality using the Newcastle-\nOttawa Scale. Data were analyzed using fixed-effect or random-effect models based on\nheterogeneity, with statistical significance set at p < 0.05.\nResults. The search identified 58 articles, with 16 meeting the criteria for review.5 studies,\nencompassing 395 patients, were included in the final analysis. 4 studies compared ablation and\ncystectomy. Recurrence rates varied, with ablation rangingfrom 0% to 37.7% and cystectomy from\n0% to 22%. Meta-analysis revealed a non-significant trend toward higher recurrence rates with \ncystectomy (OR 1.99, 95% CI 0.95-4.16, p=0.07). The heterogeneity was low (I2=0%, p=0.45).\nConclusions. This systematic review and meta-analysis did not find a statistically significant \ndifference in recurrence rates between ablation and cystectomy for treating ovarian \nendometriomas. However, there was a non-significant trend favoring ablation. Further randomized \ncontrolled trials are necessary to confirm these findings and to better understand the long-term \nefficacy and safety of ablation compared to cystectomy. \n\nManuscript accepted for publication\nKey words \nEndometriosis; ovarian endometrioma; ablation; laparoscopic cystectomy; recurrence rate. \n \nINTRODUCTION \nEndometriosis, a condition affecting about 10% of women of childbearing age, involves the \ndisplacement of endometrial tissue outside the uterus [1-2]. Ovarian endometriosis, also known as \nendometriomas, is its most frequent presentation and involves several therapeutic approaches. \nWhile laparoscopic cystectomy, also called stripping, is the current standard, surgery can cause \ndamage to ovarian tissue, diminishing its endocrinological and reproductive potential [3]. Various \napproaches have been studied to minimize this risk [4]. Among these, ablation, which involves \ndestroying the endometriosis cells by applying energy from different sources, but which has in \ncommon the thermal damage done to the endometrioma, has found increasing use in recent years \n[5]. Although it is now considered an alternative method to laparoscopic stripping, the scarcity of \nprospective studies raises questions about its efficacy in terms of risk of disease recurrence. \nRecently, a meta-analisys has shown its minor impact on ovarian function [6].  \nIn contrast, solid data on its efficacy over time in controlling the development of new \nendometriomas are lacking in the literature. Moreover, the lack of standardization of the technique \nmay make it even more challenging to understand its efficacy fully. This is why we wanted to \ncollect all the data to date in the literature on this topic. This systematic review and meta-analysis \naim to assess ablation’s recurrence outcomes compared to standard cystectomy for ovarian \nendometriomas.  \nMATERIAL AND METHODS \nThe methods for this study were specified a priori based on the recommendations in the Preferred \nReporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement \n[9]. We registered \nthe Review for meta-analysis on the PROSPERO site with protocol number CRD549177. \nSearch Method \nWe performed systematic research for records about the use of sclerotherapy in man-aging \novarian endometriomas in PubMed, EMBASE, Scopus, Google Scholar, Clinical-trials.gov, and the \nCochrane Central Register of Controlled Trials in May 2024. We did not restrict country or year of \npublication and considered only entirely English-published studies. We adopted the following string \nof idioms in each database to identify studies fitting to our review’s topic: “Endometriosis and \nAblation”.  \nStudy Selection \nStudy selection was made independently by G.A. and M.G.V. In case of discrepancy, C.R. decided \non inclusion or exclusion. Inclusion criteria were: (1) studies that included patients with at least one \novarian endometrioma, treated with Ablation and/or cystectomy; (2) studies reporting the outcome \nof interest: Recurrence Rate (RR); (3) Studies with at least 12 months of follow-up; (4) peer-\nreviewed articles, published originally. We excluded non-original studies, pre-clinical trials, animal \ntrials, abstract-only publications, and articles in languages other than English. If possible, the \nauthors of studies that were published as conference abstracts were tried to be contacted via e-\nmail and asked to provide their data. We mentioned the studies selected and all reasons for \nexclusion in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) \nflowchart (Fig. 1). We assessed all included studies regarding potential conflicts of interest.  \n \n\nManuscript accepted for publication\nStatistical analysis  \nHeterogeneity among the studies was tested using the Chi-square test and I-square tests [7]. The \nOdds Ratio (OR) and 95% confidence intervals (CI) were used for dichotomous variables. Fixed-\neffect models conducted statistical analysis without significant heterogeneity (I2<50%), or random-\neffect models if I2>50%. Recurrence rate (RR) was used as clinical outcomes. In each study, RR \nwas defined as the percentage of recurrence till the last follow-up. Chi-square tests were used to \ncompare continuous variables. Review Manager version 5.4.1 (REVman 5.4.1) and IBM Statistical \nPackage for Social Science (IBM SPSS vers 25.0) for MAC were used for statistic calculation. For \nall performed analyses, a p-value <0.05 was considered significant.  \nQuality assessment  \nWe assessed the quality of the included studies using the Newcastle– Ottawa scale (NOS) \n[8]. This \nassessment scale uses three broad factors (selection, comparability, and exposure), with the \nscores ranging from 0 (lowest quality) to 8 (best quality). Two authors (CR and II) independently \nrated the study's quality. Any disagreement was subsequently resolved by discussion or \nconsultation with PDF. We reported NOS Scale in Appendix. \nWe used a funnel plot analysis to assess publication bias. We used Egger's regression test to \ndetermine the asymmetry of funnel plots (Appendix). \nRisk of Bias \nThe RCTs and prospective cohort studies were separately assessed, and the risk of bias in these \nstudies was low or moderate. Saito et al. [11] only included nulliparae in the ablation group and \nreported bigger dimensions of endometrioma in the ablation group. In addition, he has the shortest \nfollow-up and has not reported any recurrence events in either group during these twelve months. \nHaghgoo et al. included 30 patients with unilateral endometrioma and 30 with bilateral \nendometrioma [9]. Candiani et al. used a CO2 fiber laser for cyst vaporization [12], whereas argon \nis employed commonly. \nRESULTS \nStudies’ Characteristics \nAfter the database search, 58 articles matched the search criteria. After removing records with no \nfull text, duplicates, and wrong study designs (e.g., reviews), 16 were eligible. 5 matched the \ninclusion criteria and were included in the systematic review. 4 were comparative studies between \nthe Ablation technique and laparoscopic stripping and were included in quantitative analysis (Fig \n1). The countries where the studies were conducted, the publication year range, the studies’ \ndesign, Follow-up months, and the number of participants are summarized in Table 1.  \nNOS [8] (Appendix) assessed the quality of all studies. Overall, the publication years ranged from \n2011 to 2021. In total, 395 patients with endometrioma were enrolled: 215 were treated with \nablation and 180 with laparoscopic stripping.  \nOutcomes \nThe review included 395 patients. All 5 selected studies presented RR data. Overall, the RR \nranged from 0 to 37.7% in the ablation group and from 0 to 22.0% in the stripping group. The \nfollow-up period ranged from 12 to 64 months on average.  Those results are summarized in Table \n2. \nBy alphabetic, Candiani et al [12] reported a RR of 6.3 vs 4.9 for ablation compared to stripping in \n29 months of Follow-up (p=0.74). Carmona et al [10] reported the oldest series with the highest RR \nin both arms (22% vs 37%, p=0.4) and longest Follow-Up (64 months). On the contrary, Chen et al \n\nManuscript accepted for publication\n[13] is the newest one, with RR 4.4% vs 16.7% (p=0.11) and 31 months of observation. Haghgoo \net al [9] reported the only single-arm trial with no recurrence reported after 15 months. Finally Saito \net al [11] did not observed recurrence in both arms. \nAblation Procedure \nHaghgoo et al. avoided hot energy devices, as cautery, on ovaries for ablation [9]. In Carmona et \nal. study, the vaporization of the cyst’s internal wall was performed through CO2 laser at 30 W/cm² \npower density [10]. Saito et al. performed vaporization using bipolar current forceps (35 W) on the \ninternal wall [11]. Candiani et al. used a CO2 fiber laser in a “one-step” procedure [12]. In Chen et \nal. study, bipolar forceps were applied on the internal wall at 30W until the color of the cyst turned \nwhite [13]. The average duration of contact between the forceps and the lesion was approximately \n1 second [13]. In all cases, a biopsy was performed before proceeding with vaporization [9-13]. \nMeta-analysis \nThe 4 studies comparing ablation and stripping were enrolled in the meta-analysis. A total of 337 \npatients were analyzed. 157 patients in the ablation arm were compared with 180 patients who \nunderwent cystectomy, exploring RR outcome. 23 recurrences occurred in the ablation group and \n14 in the stripping. Because of low heterogeneity (I\n2=0%; p = 0.45), the fixed-effects model was \napplied. The Cystectomy group showed a slightly non-significant higher risk for recurrence than the \nablation arm (RR 1.99 [95% CI 0.95-4.16] p=0.07). Fig 2. \n \nDISCUSSION \nMain Findings \nThis systematic review and meta-analysis included five studies, four cohort studies, and one \nrandomized trial. The qualitative data analysis could not show a statistically significant difference \nbetween the ablation technique and laparoscopic stripping based on recurrence (p=0.07). \nHowever, stripping seems to show a worsening trend with an OR per recurrence of 1.99 and a \n95% CI slightly including neutrality (0.95-4.16). This could be confirmed as the sample size \nincreases. Moreover, the largest weighting (51.1%) is represented by Carmona et al [10] which has \nthe advantage of being the only randomised clinical trial and the disadvantage of being the oldest \nincluded study, risking being flawed by a technological backwardness, which may undermine the \nefficacy of the ablative technique. \nComparison with existing literature. \nSince its first publication, ablation has been an attractive alternative for treating endometriomas. \nThis is because the relationship between endometriosis and infertility is an intrinsic one, worsened \nby all treatment episodes of a surgical nature. Cyst removal inevitably results in a reduction in the \npatient's reproductive and endocrinological potential. Much scientific society has struggled to \nminimize this impact, on the one hand, by attempting to optimize post-stripping coagulation \ntechniques [3] and, on the other hand in, seeking alternative approaches for treating \nendometrioma, such as sclerotherapy [4]. In the same vein, all alternatives provided to stripping, \nincluding ablation, have always been weighed first in assessing their impact on fertility. Recently, \nZhang et al [5] published a meta-analysis on pre- and postoperative differences in AMH and Antral \nFollicle Count (AFC) determined by ablation and stripping. The 294 patients enrolled in this meta-\nanalysis showed a lower AFC in the stripping arm, both in the immediate postoperative period \n(mean differences [MD], 1.33; 95% credible interval, 2.15 to 0.51; I2 1⁄4 57%), and at 6-month \nfollow-up (MD, 1.93; 95% credible interval, 2.40 to 1.45; I2 1⁄4 0%). The intragroup comparisons of \nAMH levels supported negative effects on ovarian reserve of both cystectomy (MD, 1.26; 95% \ncredible interval, 1.64 to 0.88; I2 1⁄4 45%) and ablation (MD, 0.70; 95% credible interval, 1.07 to \n\nManuscript accepted for publication\n0.32; I2 1⁄4 0%). These data support the evidence from another systematic review on the use of \ncystectomy [14] and a meta-analysis [15] conducted by two independent groups. A group in our \nanalysis also published data from the same series on this subject, with a more significant impact of \ncystectomy on AMH and AFC [16]. On the other hand, much rarer are the papers that focus on \nablation’s efficacy regarding recurrence risk. In this scenario, to our knowledge, our meta-analysis \nstands as the only meta-analysis focusing on this topic. \nClinical Implication \nOnce the lower impact on patients' fertility has been established, it is also essential to weigh up the \neffectiveness of the ablative technique over time. This is why, in our opinion, the evidence derived \nfrom our work supports the therapeutic choices for treating patients with endometriosis. \nEndometriosis is a chronic condition where gaining time between treatment episodes is crucial to \noptimizing treatment. To date, surgery remains the diagnostic gold standard, but this contrasts with \nthe need to be minimally invasive. This discrepancy often creates diagnostic delays that condition \nthe severity of the clinical presentation [17]. On the one hand, we need to optimize diagnosis by \nidentifying biomarkers, such as liquid biopsy [18], that can intercept our patients before organic \nprogression, and on the other hand, we need to improve our therapeutic options to chronicle the \ndisease with as little morbidity as possible. Fortunately, the pharmacological landscape has \nrecently expanded with new drugs such as Relugolix, which have shown promising results in \ncontrolling symptoms [19]. Surgery should go hand in hand with adapting to the growing number of \ntherapeutic options. In this scenario, we believe standardization of the ablative technique would \nalso be fundamental to improve its reproducibility. \nStrengths and Limitations  \nOur study is the first meta-analysis to evaluate whether cystectomy or ablation results in higher \nendometrioma RR. Unfortunately, very few studies on this subject limit our case series to 395. Our \nresults were not statistically significant, even though they showed a clear trend against cystectomy. \nAnother limitation is the lack of standardization in ablative techniques and hemostatic approaches \nin the case of stripping. This attempt to compare the two methods is more ambitious.  \nFurthermore, studies that have used bipolar coagulation have not reported any data on its \nintensity. A further limitation is the possibility of bilateral neoformations, which were included in the \nstudies as a single patient, even though it is assumed that the double procedure exposes one to a \ndouble risk of recurrence. Finally, no data have been reported regarding spillage during treatment, \nwhich may promote intraabdominal spillage of endometriosis tissue and increase the chances of \nrecurrence [20-21]. \nFinally, a final point should be made that our review does not take into account additional \noutcomes that may differentiate the two techniques, such as the risk of postoperative pain [22] or \nthe risk of malignant transformation [23]. \nCONCLUSIONS \nOur study failed to show a statistically significant (p=0.07) increased safety profile of ablation \ncompared to cystectomy in terms of RR. However, the data show a clear trend with almost doubled \nrisk of recurrence in patients undergoing laparoscopic cystectomy (OR 1.99 CI 95% 0.95-4.16). \nFurther randomised trials may support or refute this trend. \nAuthor contributions \nCarlo Ronsini: Conceptualization; Formal analysis; Methodology; Project administration; Software; \nSupervision; Validation; Writing - original draft; Writing - review & editing, Irene Iavarone: Data \ncuration; Writing - review & editing, Maria Giovanna Vastarella: Data curation; Investigation; Project \nadministration; Software; Supervision, Clorinda Vitale: Data curation, Investigation, Giada Andreoli: \n\nManuscript accepted for publication\nData curation; Formal analysis; Marco Torella: Supervision; Validation; Visualization; Pasquale de \nFranciscis: Supervision; Validation; Visualization.  \nFunding  \nNone.  \nStudy registration  \nWe registered the Review for meta-analysis on the PROSPERO site with protocol number \nCRD549177.  \nCompeting interests statement  \nThe authors of the manuscript have nothing to disclosure about it. ETHICAL APPROVAL Not \napplicable.  \nInformed consent  \nNot applicable.  \nData sharing  \nNo dataset was made to collect data for this article. Literature data are present in the reference list.  \n \nREFERENCES \nREFERENCES \n1. Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. \n2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012. PMID: 22819144; \nPMCID: PMC3836682. \n2. Sanchez AM, Viganò P, Somigliana E, Panina-Bordignon P , Vercellini P, Candiani M. The \ndistinguishing cellular and molecular features of the endometriotic ovarian cyst: from \npathophysiology to the potential endometrioma�mediated damage to the ovary. Hum \nReprod Update. 2014;20(2):217-30. doi: 10.1093/humupd/dmt053. Epub 2013 Oct 14. \nPMID: 24129684. \n3. Riemma G, De Franciscis P , La Verde M, Ravo M, Fumiento P , Fasulo DD, Della Corte L, \nRonsini C, Torella M, Cobellis L. 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Iavarone I, Greco PF, La Verde M, Morlando M, Torella M, de Franciscis P , Ronsini C. \nCorrelations between Gut Microbial Composition, Pathophysiological and Surgical Aspects \nin Endometriosis: A Review of the Literature. Medicina (Kaunas). 2023;59(2):347. doi: \n10.3390/medicina59020347. PMID: 36837548; PMCID: PMC9962646. \n21. Ronsini C, Mosca L, Iavarone I, Nicoletti R, Vinci D, Carotenuto RM, et al. Oncological \noutcomes in fertility-sparing treatment in stage IA-G2 endometrial cancer. Front Oncol. \n2022 Sep 16;12:965029. doi: 10.3389/fonc.2022.965029. \n22. Buzzaccarini G, Török P , Vitagliano A, Petousis S, Noventa M, Hortu I, et al. Predictors of \nPain Development after Laparoscopic Adnexectomy: A Still Open Challenge. J Invest Surg. \n2022 Jun;35(6):1392-1393. doi: 10.1080/08941939.2022.2056274 \n23. Ferrari F, Giannini A. Approaches to prevention of gynecological malignancies. BMC \nWomens Health. 2024 Apr 23;24(1):254. doi: 10.1186/s12905-024-03100-4. \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n\nManuscript accepted for publication\nTable 1. Characteristics of included studies. \nAuthor, \nyear of \npublication \nCountry Period of \nenrollmen\nt \nStudy \ndesign \nNo. of \nparticipant\ns \nAblation  Cystecto\nmy \nHaghgoo et \nal. 2021 [9] \nIran 2017-2019 Prospective \nMonocenter \nCohort \n58 0 58 \nCarmona et \nal. 2011 [10] \nSpain N/A Prospective \nMonocenter \nRandomize\nd \n74 38 36 \nSaito et al. \n2017 [11] \nJapan 2011-2013 Prospective \nMonocenter \nCohort  \n62 28 34 \nCandiani et \nal. 2019 [12] \nItaly 2015-2018 Prospective \nMonocenter \nCohort  \n125 61 64 \nChen et al. \n2021 [13] \nChina 2016 Retrospectiv\ne \nMonocenter \nCohort \n76 30 46 \nFU: follow-up. \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n\nManuscript accepted for publication\nTable 2. Outcomes. \nAuthor, year \nof \npublication \nCystectomy RR \n(%) \nAblation RR \n(%) \nP-\nvalue \nMedian FU \nperiod \n(months) \nSingle-arm studies  \nHaghgoo et \nal. 2021 [9] \n- 0.0 N/A 15.0 \nComparative studies  \nCarmona et \nal. 2011 [10] \n22.0 37.0 0.4 64.0 \nSaito et al. \n2017 [11] \n0.0 0.0 N/A 12.0 \nCandiani et \nal. 2019 [12] \n6.3 4.9 0.74 29.0 \nChen et al. \n2021 [13] \n4.4 16.7 0.11 31.38 \nRR: recurrence rate. \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n\nFigure 1. Flowchart. \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n  \n \n \n \n \n \n \n \n \n \n  \n \n \nRecords identified through PubMed \ndatabase searching \nn=12 \nScreening Included Eligibility Identification \nRecords removed by selection from title \nn=21 \nRecord titles screened \nn=37 \nDuplicates removed \n0 \nArticle abstracts screened \nn=37 \nRecords excluded by \nselection from abstract \n \nFull-text articles assessed \nfor eligibility \nn=11 \nRecords identified through Scopus \ndatabase searching \nn=46 \nRecords identified through \nEMBASE, Cochrane Library, \nand ScienceDirect database \nsearching  \nn=0 \nStudies included in \nqualitative synthesis \nn=1 \nFull-text articles excluded, \nwith reasons: \nn=3, not in English; \n     \nStudies included in \nquantitative synthesis \nn=5 \nManuscript accepted for publication\n\n \nFig 2. Forrest Plot \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \nManuscript accepted for publication\n\nAPPENDIX \nAppendix A. Newcastle-Ottawa Scale. \nAuthor, \nyear of \npublicatio\nn \nCountry Selection Comparabilit\ny \nExposur\ne \nTotal \nSingle-arm studies \nHaghgoo \net al. 2021 \nIran 3 1 1 5 \nComparative studies – Ablation vs. Cystectomy \nCarmona \net al. 2011 \nItaly 3 2 2 7 \nSaito et al. \n2017 \nJapan 2 1 2 5 \nCandiani \net al. 2019 \nItaly 2 1 3 6 \nChen et al. \n2021 \nChina 2 2 3 7 \n \nAppendix-B Funnel Plot \n \n \n \nManuscript accepted for publication","source_license":"CC0","license_restricted":false}