Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Endometriomas may cause progressive damage to ovarian tissue through both mechanical effects and direct toxic effects related to the inflammatory and oxidative content of the cyst, ultimately leading to a reduction in ovarian reserve. When medical treatment is insufficient or not indicated, surgery represents a therapeutic option. The aim of surgery is to remove the cyst while minimizing the risk of recurrence and preserving as much healthy ovarian tissue as possible. Currently, the most widely used surgical technique is laparoscopic cystectomy performed by stripping the cyst capsule. However, this procedure may result in the inadvertent removal of healthy ovarian tissue and a consequent reduction in ovarian reserve. In recent years, ablative surgical techniques have been developed with the aim of reducing damage to the ovarian parenchyma. Among these, Argon Plasma Coagulation (APC) is a technique that uses a high-energy argon plasma jet to vaporize and coagulate superficial tissues. From a histological perspective, APC induces limited-depth tissue necrosis, generally confined to the cyst capsule, potentially reducing the risk of damage to the underlying ovarian tissue. In addition, this technology may offer practical and economic advantages. Several studies suggest that ablative techniques may have a lower impact on ovarian reserve compared with cystectomy, as assessed by antral follicle count and serum anti-Müllerian hormone (AMH) levels, a reliable biomarker of ovarian reserve. However, the available evidence mainly derives from observational studies or studies using ablative technologies different from the one investigated in the present study. Furthermore, the systematic use of ablative techniques remains controversial in clinical practice, partly because of the potential risk of recurrence associated with residual endometriotic tissue. To date, no randomized clinical trials have directly compared the impact of APC versus cystectomy on ovarian reserve in patients with ovarian endometrioma. Moreover, data are lacking regarding recurrence risk, post-treatment ovarian ultrasound characteristics following APC ablation, and the histological effects of this technique on endometriotic cysts. In light of these considerations, the present randomized clinical trial aims to compare the effect of cystectomy and Argon Plasma Coagulation ablation on the preservation of ovarian reserve in patients undergoing surgical treatment for ovarian endometrioma, while also evaluating ultrasound outcomes and recurrence risk during follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
146
Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
Late effects of APC or cystectomy on the AFC of the treated ovary
Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 12 months (T2).
Time frame: 12 months after surgery (T2).
Early effects of APC or cystectomy on the AFC of the treated ovary
Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 40-60 days after surgery (T1).
Time frame: 40-60 days after surgery (T1).
Late effects of APC or cystectomy on serum AMH levels
Change in serum AMH levels (ΔAMH) between baseline (T0) and 12 months (T2).
Time frame: 12 months after surgery (T2).
Early effects of APC or cystectomy on serum AMH levels
Change in serum AMH levels (ΔAMH) between baseline (T0) and 40-60 days after surgery (T1).
Time frame: 40-60 days after surgery (T1).
Temporal pattern of AFC variation
Antral follicle count (AFC) values of the ovary treated with APC and cystectomy
Time frame: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Temporal pattern of AMH variation
Serum AMH levels in patients undergoing APC and cystectomy
Time frame: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Ultrasound appearance of the ovary treated with APC
Presence/absence of an ovarian cyst; cyst volume; cyst echogenicity (isoechoic, hyperechoic, hypoechoic, ground-glass appearance).
Time frame: 40-60 days after surgery (T1)
Ultrasound recurrence rate of endometrioma
Presence/absence of an ovarian cyst with ground-glass content ≥ 10 mm
Time frame: 12 months after surgery (T2)
Histological appearance of the capsule of endometriomas treated with APC
Maximum depth of necrosis; persistence of endometriotic foci
Time frame: 40-60 days after surgery (T1), (during histological analysis of surgical specimens)
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