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

July 14, 2026 updated by: The First Affiliated Hospital of Soochow University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Transumbilical Laparoendoscopic Single-Site Surgery
Total hysterectomy performed through a single incision made at the umbilicus, using specialized single-port access devices.
Active Comparator: 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.
Procedure: Multi-Port Laparoscopic Surgery
Total hysterectomy performed through 3 to 4 small incisions in the abdomen, using conventional laparoscopic instruments and ports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively
Time Frame: 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.
Within 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Hemoglobin Level
Time Frame: Postoperative Day 1
Hemoglobin concentration measured on the first postoperative morning (Day 1).
Postoperative Day 1
Hemoglobin Decrease
Time Frame: From baseline to Postoperative Day 1
Calculated as preoperative hemoglobin minus postoperative Day 1 hemoglobin.
From baseline to Postoperative Day 1
Estimated Blood Loss (EBL)
Time Frame: Intraoperative
Intraoperative blood loss volume estimated by the attending surgeon.
Intraoperative
Blood Transfusion Rate
Time Frame: Intraoperative to 7 days postoperatively
Proportion of patients receiving allogeneic or autologous blood transfusion during or after surgery.
Intraoperative to 7 days postoperatively
Time to First Flatus
Time Frame: From end of surgery to event (within 7 days)
Time interval from the end of surgery to the first passage of flatus.
From end of surgery to event (within 7 days)
Rate of successful voiding following urinary catheter removal
Time Frame: From catheter removal 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
Time Frame: At 24 hours postoperatively
Pain intensity assessed using the Visual Analogue Scale (0-10 cm, 0 = no pain, 10 = worst possible pain) at 24 hours postoperatively.
At 24 hours postoperatively
Patient Scar Assessment Scale (PSAS)
Time Frame: At 3 months postoperatively
Patient-reported scar evaluation using the PSAS component of the POSAS, assessing six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item scored 1-10. Total score ranges 6-60 (higher = worse scar).
At 3 months postoperatively
Observer Scar Assessment Scale (OSAS)
Time Frame: At 3 months postoperatively
Clinician-rated scar evaluation using the OSAS component of the POSAS, assessing six items: vascularity, pigmentation, thickness, relief, pliability, and surface area. Each item scored 1-10. Total score ranges 6-60 (higher = worse scar).
At 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024105 (South-Eastern Norway Regional Health Authority)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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