A Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy

A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy

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.

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.

Inclusion Criteria:

1. age ≥ 18 years;
2. an indication for total hysterectomy, including leiomyoma, adenomyosis, abnormal uterine bleeding, high-grade squamous intraepithelial lesion (HSIL) or endometrial intraepithelial neoplasm (EIN);
3. 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.

Exclusion Criteria:

1. concomitant vulvar, vaginal, or appendiceal pathologies requiring concurrent surgical intervention;
2. confirmed or suspected invasive malignancy.