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临床试验/NCT07519213
NCT07519213已完成不适用

Guangdong Retrospective Clinical Cohort Study of Endometriosis

Guangdong Women and Children Hospital1 个研究点 分布在 1 个国家目标入组 1,121 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,121
试验地点
1
主要终点
Recurrence of ovarian endometrioma within 2 years after surgery

研究概览

简要总结

This retrospective cohort study evaluates the association between postoperative hormonal treatment and recurrence of ovarian endometriosis in women undergoing surgery for ovarian endometrioma. The study includes patients treated at a single center who initiated one postoperative hormonal regimen after surgery. The main objective is to compare the risk of recurrence among women receiving combined oral contraceptives, gonadotropin-releasing hormone agonists, dienogest, or dydrogesterone. Recurrence is assessed during follow-up based on postoperative clinical and ultrasound findings. The results may help clarify the comparative effectiveness of commonly used postoperative hormonal strategies for reducing recurrence after surgery for ovarian endometrioma.

详细描述

This is a single-center retrospective cohort study designed to evaluate the association between postoperative hormonal therapy and recurrence of ovarian endometrioma after conservative surgery.

Women who underwent surgery for ovarian endometrioma at the study center were screened for eligibility. Patients were included if they initiated one postoperative hormonal regimen within 1 month after surgery and continued the same single-agent treatment for at least 6 months. Patients who did not meet the continuous treatment requirement, received sequential hormonal therapy, or otherwise failed to meet the eligibility criteria were excluded.

Eligible participants were classified into 4 cohorts according to the postoperative hormonal regimen received: combined oral contraceptives (COC), gonadotropin-releasing hormone agonists (GnRH-a), dienogest (DNG), and dydrogesterone. The study was observational in nature, and treatment allocation was based on routine clinical practice rather than assignment by investigators.

The primary objective is to compare recurrence risk among the 4 postoperative hormonal treatment groups. Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 examinations during follow-up. Follow-up focuses on recurrence within 2 years after surgery.

Clinical, demographic, and disease-related characteristics are collected from medical records and follow-up data. These variables include baseline patient characteristics, reproductive history, disease severity, and relevant surgical findings. The study aims to assess the comparative effectiveness of commonly used postoperative hormonal strategies for long-term management after conservative surgery for ovarian endometrioma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients who underwent conservative surgery for ovarian endometrioma at the study center.
  • Initiation of one postoperative hormonal regimen within 1 month after surgery.
  • Continuous use of the same single hormonal regimen for at least 6 months after surgery.
  • Availability of clinical records and postoperative follow-up data for assessment of study outcomes.

排除标准

  • Failure to initiate postoperative hormonal therapy within 1 month after surgery.
  • Discontinuation of the postoperative hormonal regimen before 6 months.
  • Use of sequential or multiple postoperative hormonal therapies during the initial treatment period.
  • Incomplete clinical records or insufficient follow-up data for evaluation of recurrence.

研究组 & 干预措施

Dydrogesterone

Participants who received dydrogesterone as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma.

COC

Participants who received combined oral contraceptives as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma.

GnRH-a

Participants who received gonadotropin-releasing hormone agonists as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma.

DNG

Participants who received dienogest as postoperative hormonal therapy in routine clinical practice after surgery for ovarian endometrioma.

结局指标

主要结局

Recurrence of ovarian endometrioma within 2 years after surgery

时间窗: Within 2 years after surgery

Recurrence is defined as a newly detected ovarian cyst measuring at least 2 cm on ultrasound and documented on at least 2 separate examinations during follow-up.

次要结局

未报告次要终点

研究者

发起方
Guangdong Women and Children Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Li

Professor

Guangdong Women and Children Hospital

研究点 (1)

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