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

NCT06817460 | Completed

• 1 other identifier: 2024105
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Approaches; Enhanced Recovery After Surgery; Benign Tumor of Uterus

Keywords

hysterectomy; single-port; multi-port; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Comprehensive ERAS Achievement Rate at 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.

  Within 24 hours postoperatively

Secondary Outcomes (9)

• 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)

Study Arms (2)

Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group

EXPERIMENTAL

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.

Procedure: Transumbilical Laparoendoscopic Single-Site Surgery

Multi-Port Laparoscopic Surgery (MPLS) Group

ACTIVE COMPARATOR

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.

Procedure: Multi-Port Laparoscopic Surgery

Interventions

Transumbilical Laparoendoscopic Single-Site Surgery PROCEDURE

Total hysterectomy performed through a single incision made at the umbilicus, using specialized single-port access devices.

Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group

Multi-Port Laparoscopic Surgery PROCEDURE

Total hysterectomy performed through 3 to 4 small incisions in the abdomen, using conventional laparoscopic instruments and ports.

Multi-Port Laparoscopic Surgery (MPLS) Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: February 10, 2025
• Study Start: February 12, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 15, 2026

Record last verified: 2025-02

Locations

CN (1)