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

Conditions: Benign Tumor of Uterus, Surgical Approaches, Enhanced Recovery After Surgery

Sex: Female

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: NA

Enrollment: 312

Sponsor: The First Affiliated Hospital of Soochow University

Location: The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06817460). StuddyBuddy aggregates publicly available trial information.