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临床试验/NCT06219044
NCT06219044已完成不适用

Ovarian Reserve, Recurrence Rate and Histopathologic Evaluation After DWLS Diode Laser Vaporization of Ovarian Endometriomas: Results From a Prospective, Multicentre, Clinical Trial.

University of Cagliari2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Evaluation of the patients' symptoms

研究概览

简要总结

PURPOSE OF THE STUDY The study aims to evaluate the effectiveness of the Dual Wavelength Laser System (DWLS) diode laser on the treatment of endometrioma (OMA), with ablation and vaporization of the cystic capsule without performing the stripping technique, in terms of ovarian reserve and recurrence rate.

详细描述

BACKGROUND Endometriosis cyst, or endometrioma (OMA), is one of the most frequent gynaecological pathologies and is commonly associated with symptoms such as infertility and chronic pelvic pain. Randomized and meta-analysis studies demonstrate how the most effective surgery, in terms of percentages of pregnancy after surgery and minor rates of recurrence of cysts or pelvic pain, is the complete removal of the cyst wall through laparoscopic "stripping". However, data has recently emerged on the possible damage determined by "stripping" surgery on the healthy ovarian tissue adjacent to the OMA.

Studies on the anatomopathological characteristics of the wall of the OMA surgically removed have shown that, with the complete removal surgery, part of ovarian tissue is inadvertently removed together with the OMA wall in almost all cases since there is no real cleavage plan between cysts and healthy ovarian tissue. The post-surgery ovarian reserve has been reported, measured as lower levels of antimullerian hormone (AMH), minor values of antral follicular count (AFC), and reduced postoperative ovarian volumes. Worst performances have also been reported for the induction of ovulation for in vitro fertilization techniques. In the event of the removal of bilateral OMA, 2-4% of early premature ovarian failure has been reported, confirming possible surgical damage to healthy ovarian tissue. Following these data, the international scientific community has begun to question the effective superiority of the complete removal approach of the cystic wall, or "stripping", given these new acquisitions on post-surgical ovarian damage. Therefore, the theme of the best therapeutic approach to OMA has become one of the most debated in the gynaecological field. Despite the data on the possible surgical damage, surgical intervention remains one of the cornerstones of OMA therapy.

The recurrence rate evaluation is one of the primary endpoints of all OMA surgery studies. Guo S.w. has estimated a recurrence rate of 21.5% to 2 years and 40-50% to 5 years. In a recent systematic review of Ceccaroni M. et al., 12-30% recurrence rates are shown 2-5 years after surgical treatment.

An alternative technique to "stripping" is the fenestration of the cyst followed by ablation or vaporization with the laser of the internal wall of the cyst left "in situ" without the complete removal of the cystic wall with healthy ovarian tissue. Candiani et al. demonstrated, in their randomized study, that the "One Step" vaporization of the OMA capsule with the CO2 laser is more effective than stripping in reducing the residual follicular damage (in terms of AMH and AFC).

For better results regarding controlled ablation of the cystic wall of the OMA, the DWLS diode laser could be helpful. The combination of two wavelengths, 980 Nm and 1470 Nm, gives a contemporary absorption in H2O and haemoglobin with an excellent ability of hemostasis, cut and vaporization, as previously demonstrated in laparoscopic and hysteroscopic surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 and 40 years old
  • OMA mono or bilateral ≥ 3 and ≤ 8 cm in diameter
  • presence of symptoms such as pelvic pain and sterility

排除标准

  • Patients who are unable to provide written informed consent or to follow the procedures provided for by the protocol
  • Age <18 years and> 40 years
  • OMA mono or bilateral <3 and> 8 cm in diameter
  • Asymptomatic patients
  • Absence of histological confirmation of endometriosis cysts
  • previous interventions on one or both annexes
  • Failure to follow-up

结局指标

主要结局

Evaluation of the patients' symptoms

时间窗: every 3 months for one year

assessed using the Visual Analogue Scale (VAS) , from 0 as the minimum to 10 as maximum value. Higher scores mean a worse outcome

Evaluation of the ovarian reserve using AntiMullerian Hormone (AMH) assessment.

时间窗: every 3 months for one year

Blood dosage of AntiMullerian Hormone expressed in nanograms/milliliter (ng/mL)

Evaluation of the ovarian reserve using Antral follicular Count (AFC)

时间窗: every 3 months for one year

counts of the number of antral follicles present in the ovary during ultrasound scan. The count is presented in Numbers from 0 to any numbers (n°)

次要结局

  • Evaluation of pregnancy rate(every 3 months for one year)
  • Evaluation of endometrioma recurrence rate(every 3 months for one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Angioni

Full Professor

University of Cagliari

研究点 (2)

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