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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argon Plasma Coagulation (APC) ablation | Experimental | Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule. |
|
| Cystectomy | No Intervention | Removal of the cyst capsule using the stripping technique, followed by ultra-selective hemostasis with bipolar energy and suturing of the ovarian parenchyma for hemostatic and reconstructive purposes (when indicated). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argon Plasma Coagulation (APC) ablation | Procedure | Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months after surgery (T2). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 40-60 days after surgery (T1). |
| Late effects of APC or cystectomy on serum AMH levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Raimondo, MD | Contact | +393290636618 | die.raimondo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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Ovarian reserve assessment will be performed through pre- and post-operative ultrasound evaluation of the antral follicle count (AFC), carried out by an experienced blinded sonographer.
To ensure blinding, the experienced sonographer will be assisted by a second physician responsible for conducting the clinical interview with the patient, in order to provide the sonographer with the necessary clinical information while omitting any details regarding the surgical technique used.
For the present study, a stratified randomization design will be adopted. Stratification will be performed according to two clinically relevant variables: patient age (cut-off: 32 years) and maximum endometrioma diameter at preoperative ultrasound assessment (cut-off: 40 mm). These factors were selected because of their potential impact on ovarian reserve and surgical outcomes.
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Change in serum AMH levels (ΔAMH) between baseline (T0) and 12 months (T2). |
| 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). | 40-60 days after surgery (T1). |
| Temporal pattern of AFC variation | Antral follicle count (AFC) values of the ovary treated with APC and cystectomy | 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 | 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). | 40-60 days after surgery (T1) |
| Ultrasound recurrence rate of endometrioma | Presence/absence of an ovarian cyst with ground-glass content ≥ 10 mm | 12 months after surgery (T2) |
| Histological appearance of the capsule of endometriomas treated with APC | Maximum depth of necrosis; persistence of endometriotic foci | 40-60 days after surgery (T1), (during histological analysis of surgical specimens) |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |
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