Comparison of Lee-Huang Point and Umbilical Entry for Laparoscopic Surgery in Endometrial Cancer Patients: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Successful laparoscopic abdominal entry
研究概览
简要总结
This randomized controlled trial compares Lee-Huang point entry with conventional umbilical entry for laparoscopic surgery in patients with endometrial cancer. The study aims to evaluate the success of abdominal entry, entry-related complications, operative outcomes, and perioperative safety. A total of 202 patients were randomized to either the Lee-Huang entry group or the umbilical entry group and underwent laparoscopic surgical staging. The findings are expected to provide evidence regarding the optimal primary entry technique for laparoscopic management of endometrial cancer.
详细描述
This single-center prospective randomized controlled trial was conducted at the Department of Gynecologic Oncology, Kartal Dr. Lutfi Kirdar City Hospital, University of Health Sciences Turkey. Eligible patients with endometrial cancer scheduled for laparoscopic surgical staging were randomly assigned to either Lee-Huang point entry or conventional umbilical entry. The primary objective was to compare successful abdominal access and entry-related complications between the two techniques. Secondary outcomes included operative time, blood loss, conversion to laparotomy, intraoperative and postoperative complications, and other perioperative outcomes. A total of 202 patients completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Female patients aged 18 years or older.
- •Scheduled for elective laparoscopic gynecologic surgery.
- •Eligible for laparoscopic abdominal entry through either the Lee-Huang point or the umbilical entry site.
- •Provided written informed consent.
排除标准
- •Pregnancy.
- •Emergency surgery.
- •Previous upper abdominal surgery precluding safe Lee-Huang point or umbilical entry.
- •Contraindication to laparoscopy.
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Lee-Huang Point
Laparoscopic abdominal entry using the Lee-Huang point
干预措施: Laparoscopic entry through the Lee-Huang point (Procedure)
Umbilical Entry
Standard laparoscopic abdominal entry through the umbilicus
干预措施: Standart umbilical laparoscopic entry (Procedure)
结局指标
主要结局
Successful laparoscopic abdominal entry
时间窗: During surgery
Successful intraperitoneal access through the assigned entry site using direct trocar insertion without the need for conversion to another abdominal entry technique.
次要结局
- Entry-related complications(During surgery)
研究者
Özge Nur Gülen
Gynecologic Oncology Fellow
Dr. Lutfi Kirdar Kartal Training and Research Hospital