Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy) : Multicenter Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 8
- 主要终点
- Perioperative Complications
研究概览
简要总结
Since the publication of the LAP2 study, a prospective randomized trial, laparoscopy has been considered the gold standard for treating patients with early-stage endometrial cancer (EC). However, no prospective randomized trials have been published reporting comparable data in patients with EC at high risk of recurrence (advanced stages or non-endometrioid histology). Nonetheless, some retrospective studies and a systematic review of the literature have demonstrated that minimally invasive surgery achieves better perioperative outcomes than laparotomy without compromising survival in patients with EC at high risk of recurrence.
The aim of this multicenter retrospective observational study is to evaluate the safety of minimally invasive surgery in treating EC at low, intermediate, and high risk of recurrence according to the ESMO-ESGO classification, based on cases treated in hospitals within the Emilia Romagna region. Specifically, we aim to assess the effects of a minimally invasive surgical approach compared to laparotomy in terms of:
- Perioperative and postoperative complications: including the need for transfusions during and/or after surgery, duration of surgery, fever exceeding 38°C for more than 48 hours, and length of hospitalization.
- Long-term oncological outcomes: including overall survival, disease-free survival, recurrence rates, recurrence sites, and time to recurrence.
This comparison will include patients treated for both endometrioid and non-endometrioid EC to provide a comprehensive evaluation of minimally invasive surgery versus laparotomy.
By delineating the safety and efficacy of laparoscopic techniques, particularly for higher-risk patients, this research could refine surgical standards and guide clinical decision-making, emphasizing evidence-based practices for tailored patient care. The study also aligns with broader efforts to optimize cancer management in regional and national healthcare settings.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020
排除标准
- •Patients with other types of tumors (e.g., cervical or ovarian cancer).
- •Patients for whom surgical and/or post-operative data are unavailable.
- •Patients with a follow-up period of less than 6 months.
- •Patients who refuse to provide informed consent.
研究组 & 干预措施
Patients with endometrial cancer who underwent surgical treatment
All patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.
干预措施: Laparotomy (Procedure)
Patients with endometrial cancer who underwent surgical treatment
All patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.
干预措施: Laparoscopy (Procedure)
结局指标
主要结局
Perioperative Complications
时间窗: 30 days post-surgery.
This metric assesses the number of participants with perioperative complications in the two intervention groups, specifically including the need for blood transfusions (either intraoperative or postoperative), surgery duration exceeding 180 minutes, postoperative fever \>38°C lasting more than 48 hours, and hospitalization exceeding 7 days.
次要结局
- Overall Survival (OS)(Five years post-surgery (from the date of surgery up to 5 years))
- Disease-Free Survival (DFS)(Five years post-surgery (from the date of surgery up to 5 years))