Ludovico Muzii1, Chiara Achilli2, Valentino Bergamini3, Massimo Candiani4, Elisabetta Garavaglia4, Lucia Lazzeri5, Francesca Lecce2, Antonio Maiorana6, Francesco Maneschi7, Riccardo Marana8, Alessio Perandini3, Maria Grazia Porpora2, Renato Seracchioli9, Emanuela Spagnolo9, Michele Vignali10, Pierluigi Benedetti Panici2. 1. Department of Obstetrics and Gynaecology, 'Sapienza' Università di Roma, Rome, Italy ludovico.muzii@uniroma1.it. 2. Department of Obstetrics and Gynaecology, 'Sapienza' Università di Roma, Rome, Italy. 3. Department of Obstetrics and Gynaecology, Università degli Studi di Verona, Verona, Italy. 4. Department of Obstetrics and Gynaecology, Università San Raffaele, Milan, Italy. 5. Department of Obstetrics and Gynaecology, Università di Siena, Siena, Italy. 6. Department of Obstetrics and Gynaecology, Ospedale Civico, Palermo, Italy. 7. Department of Obstetrics and Gynaecology, Ospedale Santa Maria Goretti, Latina, Italy. 8. Department of Obstetrics and Gynaecology, Università Cattolica del Sacro Cuore di Roma and ISI Paolo VI, Rome, Italy. 9. Department of Obstetrics and Gynaecology, Università di Bologna, Bologna, Italy. 10. Department of Obstetrics and Gynaecology, Università degli Studi di Milano, Milan, Italy.
Abstract
STUDY QUESTION: Is the combined excisional/ablative technique for the treatment of ovarian endometriomas better than the traditional stripping technique in terms of recurrence rate? SUMMARY ANSWER: There is no evidence that the combined excisional/ablative technique is better than the traditional stripping technique, as similar recurrence rates were observed for the two techniques. WHAT IS KNOWN ALREADY: The stripping technique is associated with better results compared with ablative, non-excisional techniques for the treatment of ovarian endometriomas. Excisional techniques, such as stripping, have, however, been associated with reduced ovarian reserve as evaluated with anti-Mullerian hormone, and surgical techniques that better preserve the ovarian reserve are needed. STUDY DESIGN, SIZE, DURATION: A prospective, multicentre, randomized blinded clinical trial was carried out on 51 patients with bilateral endometriomas larger than 3 cm. For each patient, serving as her own control, one ovary was randomized to the stripping technique and the contralateral to the combined excisional/ablative technique. Patients were enrolled between January 2013 and April 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS:Patients of reproductive age with pelvic pain and/or infertility affected by bilateral endometriomas larger than 3 cm were included (n = 51). The patients underwent laparoscopic removal of endometriomas with two different surgical techniques performed at either side after random assignment: complete removal by stripping on one side versus the combined technique, consisting of partial excisional cystectomy followed by completion with ablative surgery using bipolar coagulation, on the other side. Post-operative follow-up was performed at 1, 3 and 6 months after surgery for the evaluation of endometrioma recurrence (primary outcome) and of antral follicle count (AFC) and ovarian volumes (OVs) to assess ovarian reserve (secondary outcome). MAIN RESULTS AND THE ROLE OF CHANCE: Recurrence rates were 5.9% for the stripping technique versus 2.0% for the combined technique (odds ratio 3.00; 95% confidence interval: 0.24-157.5; P = 0.62). AFC in the ovaries treated with the stripping technique did not differ significantly from AFC in ovaries treated with the combined technique at all follow-up visits, whereas OV was significantly lower after the combined technique at the 6-month follow-up visit (P = 0.04). LIMITATIONS, REASONS FOR CAUTION: A major limitation of this study is the small sample size and particularly for ovarian reserve, the secondary outcome, for which no formal sample size calculation was performed. The lower-than-expected recurrence rates in the present series may be related to the shorter follow-up in our study compared with most studies in the literature. Further studies with larger sample sizes and longer follow-up are needed to confirm the findings of this study. The combined technique using CO2 laser energy instead of bipolar coagulation should also be evaluated. WIDER IMPLICATIONS OF THE FINDINGS: The traditional excisional technique, i.e. the stripping technique, should still be considered the gold standard approach for the surgical treatment of endometriomas. STUDY FUNDING/COMPETING INTERESTS: No commercial funding was received. The authors report no relevant conflict of interest. TRIAL REGISTRATION NUMBER: ANZCTR number ACTRN12614000653662. TRIAL REGISTRATION DATE: 23 June 2014. DATE OF FIRST PATIENT'S ENROLMENT: 1 January 2013.
RCT Entities:
STUDY QUESTION: Is the combined excisional/ablative technique for the treatment of ovarian endometriomas better than the traditional stripping technique in terms of recurrence rate? SUMMARY ANSWER: There is no evidence that the combined excisional/ablative technique is better than the traditional stripping technique, as similar recurrence rates were observed for the two techniques. WHAT IS KNOWN ALREADY: The stripping technique is associated with better results compared with ablative, non-excisional techniques for the treatment of ovarian endometriomas. Excisional techniques, such as stripping, have, however, been associated with reduced ovarian reserve as evaluated with anti-Mullerian hormone, and surgical techniques that better preserve the ovarian reserve are needed. STUDY DESIGN, SIZE, DURATION: A prospective, multicentre, randomized blinded clinical trial was carried out on 51 patients with bilateral endometriomas larger than 3 cm. For each patient, serving as her own control, one ovary was randomized to the stripping technique and the contralateral to the combined excisional/ablative technique. Patients were enrolled between January 2013 and April 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS:Patients of reproductive age with pelvic pain and/or infertility affected by bilateral endometriomas larger than 3 cm were included (n = 51). The patients underwent laparoscopic removal of endometriomas with two different surgical techniques performed at either side after random assignment: complete removal by stripping on one side versus the combined technique, consisting of partial excisional cystectomy followed by completion with ablative surgery using bipolar coagulation, on the other side. Post-operative follow-up was performed at 1, 3 and 6 months after surgery for the evaluation of endometrioma recurrence (primary outcome) and of antral follicle count (AFC) and ovarian volumes (OVs) to assess ovarian reserve (secondary outcome). MAIN RESULTS AND THE ROLE OF CHANCE: Recurrence rates were 5.9% for the stripping technique versus 2.0% for the combined technique (odds ratio 3.00; 95% confidence interval: 0.24-157.5; P = 0.62). AFC in the ovaries treated with the stripping technique did not differ significantly from AFC in ovaries treated with the combined technique at all follow-up visits, whereas OV was significantly lower after the combined technique at the 6-month follow-up visit (P = 0.04). LIMITATIONS, REASONS FOR CAUTION: A major limitation of this study is the small sample size and particularly for ovarian reserve, the secondary outcome, for which no formal sample size calculation was performed. The lower-than-expected recurrence rates in the present series may be related to the shorter follow-up in our study compared with most studies in the literature. Further studies with larger sample sizes and longer follow-up are needed to confirm the findings of this study. The combined technique using CO2 laser energy instead of bipolar coagulation should also be evaluated. WIDER IMPLICATIONS OF THE FINDINGS: The traditional excisional technique, i.e. the stripping technique, should still be considered the gold standard approach for the surgical treatment of endometriomas. STUDY FUNDING/COMPETING INTERESTS: No commercial funding was received. The authors report no relevant conflict of interest. TRIAL REGISTRATION NUMBER: ANZCTR number ACTRN12614000653662. TRIAL REGISTRATION DATE: 23 June 2014. DATE OF FIRST PATIENT'S ENROLMENT: 1 January 2013.