- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07666412
Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Diego Raimondo, MD
- Puhelinnumero: +393290636618
- Sähköposti: die.raimondo@gmail.com
Opiskelupaikat
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Bologna
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Bologna, Bologna, Italia, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Ottaa yhteyttä:
- Diego Raimondo, MD
- Puhelinnumero: +393290636618
- Sähköposti: die.raimondo@gmail.com
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Symptomatic patients (pain and/or infertility) affected by ovarian endometriomas (unilateral or bilateral).
- Age between 18 and 40 years.
- Ultrasound diagnosis of one or more mono- or bilateral endometriotic cysts, with a maximum overall diameter (per ovary) ≤ 80 mm and at least one cyst diameter ≥ 20 mm.
- Use of hormonal therapy for at least 1 month prior to surgery.
- Willingness to undergo follow-up at 40-60 days and 12 months, according to clinical practice.
- Willingness to receive postoperative hormonal therapy, according to clinical practice, to minimize the risk of recurrence.
- Written informed consent obtained.
Exclusion Criteria:
- History of unilateral ovariectomy/adnexectomy or hysterectomy.
- Ultrasound evidence of other non-endometriotic ovarian cysts requiring surgical removal.
- Atypical endometrioma or ultrasound suspicion of malignancy.
- Previous surgery on one or both ovaries within 12 months prior to surgery.
- Known or suspected active oncological disease.
- Inability to undergo transvaginal ultrasound examination (patients with intact hymen).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Argon Plasma Coagulation (APC) ablation
Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.
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Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.
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Ei väliintuloa: Cystectomy
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).
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Late effects of APC or cystectomy on the AFC of the treated ovary
Aikaikkuna: 12 months after surgery (T2).
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Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 12 months (T2).
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12 months after surgery (T2).
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Early effects of APC or cystectomy on the AFC of the treated ovary
Aikaikkuna: 40-60 days after surgery (T1).
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Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 40-60 days after surgery (T1).
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40-60 days after surgery (T1).
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Late effects of APC or cystectomy on serum AMH levels
Aikaikkuna: 12 months after surgery (T2).
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Change in serum AMH levels (ΔAMH) between baseline (T0) and 12 months (T2).
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12 months after surgery (T2).
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Early effects of APC or cystectomy on serum AMH levels
Aikaikkuna: 40-60 days after surgery (T1).
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Change in serum AMH levels (ΔAMH) between baseline (T0) and 40-60 days after surgery (T1).
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40-60 days after surgery (T1).
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Temporal pattern of AFC variation
Aikaikkuna: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
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Antral follicle count (AFC) values of the ovary treated with APC and cystectomy
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Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
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Temporal pattern of AMH variation
Aikaikkuna: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
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Serum AMH levels in patients undergoing APC and cystectomy
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Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
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Ultrasound appearance of the ovary treated with APC
Aikaikkuna: 40-60 days after surgery (T1)
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Presence/absence of an ovarian cyst; cyst volume; cyst echogenicity (isoechoic, hyperechoic, hypoechoic, ground-glass appearance).
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40-60 days after surgery (T1)
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Ultrasound recurrence rate of endometrioma
Aikaikkuna: 12 months after surgery (T2)
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Presence/absence of an ovarian cyst with ground-glass content ≥ 10 mm
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12 months after surgery (T2)
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Histological appearance of the capsule of endometriomas treated with APC
Aikaikkuna: 40-60 days after surgery (T1), (during histological analysis of surgical specimens)
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Maximum depth of necrosis; persistence of endometriotic foci
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40-60 days after surgery (T1), (during histological analysis of surgical specimens)
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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Sukuelinten sairaudet, naiset
- Endometrioosi
- Terapeuttiset lääkkeet
- Kirurgiset toimenpiteet, operatiivinen
- Ablaatiotekniikat
- Hemostaattiset tekniikat
- Elektromoagulaatio
- Kattila
- Hemostaasi, kirurginen
- Argon Plasma -hyytyminen
Muut tutkimustunnusnumerot
- ARG-OMA
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