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NCT Number: NCT06817460

A 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.

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Key information

Conditions

Benign Tumor of Uterus Enhanced Recovery After Surgery Surgical Approaches

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Transumbilical Laparoendoscopic Single-Site Surgery

Procedure

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

Multi-Port Laparoscopic Surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Hemoglobin Level

    Time frame: Postoperative Day 1

    Hemoglobin concentration measured on the first postoperative morning (Day 1).

  2. Hemoglobin Decrease

    Time frame: From baseline to Postoperative Day 1

    Calculated as preoperative hemoglobin minus postoperative Day 1 hemoglobin.

  3. Estimated Blood Loss (EBL)

    Time frame: Intraoperative

    Intraoperative blood loss volume estimated by the attending surgeon.

  4. Blood Transfusion Rate

    Time frame: Intraoperative to 7 days postoperatively

    Proportion of patients receiving allogeneic or autologous blood transfusion during or after surgery.

  5. 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.

  6. 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

  7. 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.

  8. 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).

  9. 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).

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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