A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively
研究概览
简要总结
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases.
详细描述
Enhanced recovery after surgery (ERAS) is a multidisciplinary strategy to improve perioperative outcomes and accelerate patient recovery. This study aims to compare ERAS-related and perioperative outcomes between multi-port laparoscopic surgery (MPLS) and transumbilical laparoendoscopic single-site surgery (TU-LESS) in patients undergoing total hysterectomy for benign or premalignant uterine diseases. Eligible patients will be randomly assigned to undergo MPLS or TU-LESS. The primary outcome is the 24-hour postoperative comprehensive ERAS compliance rate. Secondary outcomes include operative time, postoperative hemoglobin, intraoperative estimated blood loss, transfusion rate, time to first flatus, 24-hour postoperative visual analogue scale (VAS) pain score, rate of successful voiding following urinary catheter removal, and 3-month patient and observer scar assessment scale (POSAS) scores.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years;
- •an indication for total hysterectomy, including leiomyoma, adenomyosis, abnormal uterine bleeding, high-grade squamous intraepithelial lesion (HSIL) or endometrial intraepithelial neoplasm (EIN);
- •and a thorough understanding of the risks and benefits of both TU-LESS and MPLS surgical approaches, willingness to undergo either procedure, and provision of written informed consent.
排除标准
- •concomitant vulvar, vaginal, or appendiceal pathologies requiring concurrent surgical intervention;
- •confirmed or suspected invasive malignancy.
研究组 & 干预措施
Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group
Patients undergoing total hysterectomy via transumbilical laparoendoscopic single-site surgery (TU-LESS) under standardized ERAS protocol. Perioperative management follows the same ERAS pathway as the comparator group.
干预措施: Transumbilical Laparoendoscopic Single-Site Surgery (Procedure)
Multi-Port Laparoscopic Surgery (MPLS) Group
Patients undergoing total hysterectomy via conventional multi-port laparoscopic surgery (MPLS) under standardized ERAS protocol. This serves as the active control representing current standard surgical practice.
干预措施: Multi-Port Laparoscopic Surgery (Procedure)
结局指标
主要结局
Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively
时间窗: Within 24 hours postoperatively
The proportion of patients achieving all five predefined ERAS criteria simultaneously within 24 hours post-surgery: (1) oral liquid intake tolerated; (2) first flatus passed; (3) spontaneous urination after catheter removal; (4) ambulation; and (5) Visual Analogue Scale (VAS) pain score ≤ 3. Failure to meet any single criterion within 24 hours is defined as non-achievement. This is a composite primary outcome measure.
次要结局
- Postoperative Hemoglobin Level(Postoperative Day 1)
- Hemoglobin Decrease(From baseline to Postoperative Day 1)
- Estimated Blood Loss (EBL)(Intraoperative)
- Blood Transfusion Rate(Intraoperative to 7 days postoperatively)
- Time to First Flatus(From end of surgery to event (within 7 days))
- Rate of successful voiding following urinary catheter removal(From catheter removal to event (within 7 days))
- 24-Hour Postoperative VAS Pain Score(At 24 hours postoperatively)
- Patient Scar Assessment Scale (PSAS)(At 3 months postoperatively)
- Observer Scar Assessment Scale (OSAS)(At 3 months postoperatively)