Assessment of ovarian reserve after cystectomy versus ‘one-step’ laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial
M. Candiani, J. Ottolina, E. Posadzka, S. Ferrari1, L. M. Castellano, I. Tandoi, L. Pagliardini, A. Nocuń, R. Jach
Human Reproduction, 2018
Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial.
La preoccupazione per il danno alla riserva ovarica legata all’asportazione di tessuto ovarico sano insieme alla capsula cistica ha portato all’introduzione di tecniche chirurgiche alternative, come la chirurgia ablativa con CO2 laser, che ha come intento principale di preservare la funzionalità ovarica, di conservare la riserva follicolare ma anche di rendere la procedura riproducibile oltre che più rispettosa del tessuto ovarico senza pagarne in termini di recidiva di malattia. Da circa 4 anni il Prof. Candiani e la sua equipe, unici attualmente in Italia, hanno introdotto questo approccio chirurgico che consiste nella vaporizzazione con la fibra laser CO2 della componente funzionale della cisti stessa. A differenza della tecnica tradizionale di enucleazione non comporta alcun danno a livello della corticale ovarica circostante all’endometrioma. Questo recente studio clinico condotto dal gruppo del San Raffaele, ha dimostrato i benefici del trattamento laser sulla riserva ovarica rispetto alla tecnica standard (stripping).
STUDY QUESTION: Does CO2 laser vaporization offer better results in treating endometrioma in terms of ovarian reserve preservation compared to traditional cystectomy?
SUMMARY ANSWER: Assessing both antral follicle count (AFC) and serum anti-Müllerian hormone (AMH) levels as measures of ovarian
reserve, the results suggest that CO2 technology may be an alternative treatment for endometrioma, causing minimal damage to adjacent healthy ovarian tissue.
WHAT IS KNOWN ALREADY: Excisional surgery has been questioned as an ideal surgical approach for endometriomas because it is associated with potential reduction of ovarian reserve. Recently, vaporization with CO2 laser in-line-of-sight, according to the ‘three-step procedure’, has been proposed as the best method to preserve ovarian function. However, no randomized controlled trials have been conducted to compare cystectomy and ‘one-step’ CO2 fiber laser vaporization (without GnRH agonist therapy) with respect to the ovarian reserve.
STUDY DESIGN, SIZE, DURATION: A multicentre randomized clinical trial including 60 patients was performed between July 2017 and February 2018. Computerized randomization was conducted to allocate them in a proportion of 1:1 either to Group 1 (laparoscopic stripping: cystectomy) or Group 2 (CO2 laser vaporization). Patients in Group 1 underwent a standardized laparoscopic stripping technique; patients in Group 2 underwent drainage of the cyst content, biopsy and vaporization of the internal wall with a CO2 fiber laser. Patients underwent pelvic ultrasound examination to determine the AFC and blood sampling to determine AMH levels before surgery and at 1- and 3-month follow-up.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients undergoing surgery for symptomatic endometriomas (infertility and/ or pelvic pain) larger than 3 cm were randomized in two groups according to the surgical technique. Patients aged ≥40 years, or with deep infiltrating endometriosis/adenomyosis, or previously submitted to surgical procedures on the ovaries or to hysterectomy were excluded
from the study. The primary endpoint was the comparison of intra-group AFC changes before and after surgery (ΔAFC) between the two groups (ΔAFC Group 1 versus ΔAFC Group 2). The secondary endpoint was the modification of serum AMH before and after surgery (ΔAMH) between the two groups (ΔAMH Group 1 versus ΔAMH Group 2).
MAIN RESULTS AND THE ROLE OF CHANCE: The AFC of the operated ovary was significantly increased in Group 2 (laser vaporization)
compared with Group 1 (cystectomy) after surgery (Group 1: from 4.1 ± 2.2 [mean ± SD] at baseline to 6.3 ± 3.5 at 3-month
follow-up; 95% CI: 0.9–4; Group 2: from 3.6 ± 1.9 at baseline to 8.6 ± 4.2 at 3-month follow-up; 95% CI: 2.8–7.1; P = 0.016); serum AMH levels were significantly reduced at 3 months in Group 1 (from 2.6 ± 1.4 ng/mL at baseline to 1.8 ± 0.8 ng/mL at 3-month follow-up; 95% CI: −1.3 to −0.2; P = 0.012) compared with no reduction in Group 2 (from 2.3 ± 1.1 ng/mL at baseline to 1.9 ± 0.9 ng/mL at 3-month follow- up; 95% CI: −1 to −0.2; P = 0.09).
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