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

The First Affiliated Hospital of Soochow University312 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

312

Conditions

Benign Tumor of Uterus

Interventions

Transumbilical Laparoendoscopic Single-Site SurgeryPROCEDURE

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

Multi-Port Laparoscopic SurgeryPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Within 24 hours postoperatively

Secondary Outcomes

Postoperative Hemoglobin Level

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

Time frame: Postoperative Day 1

Hemoglobin Decrease

Calculated as preoperative hemoglobin minus postoperative Day 1 hemoglobin.

Time frame: From baseline to Postoperative Day 1

Estimated Blood Loss (EBL)

Intraoperative blood loss volume estimated by the attending surgeon.

Time frame: Intraoperative

Blood Transfusion Rate

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

Time frame: Intraoperative to 7 days postoperatively

Time to First Flatus

Time interval from the end of surgery to the first passage of flatus.

Time frame: 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)

24-Hour Postoperative VAS Pain Score

Pain intensity assessed using the Visual Analogue Scale (0-10 cm, 0 = no pain, 10 = worst possible pain) at 24 hours postoperatively.

Time frame: At 24 hours postoperatively

Patient Scar Assessment Scale (PSAS)

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).

Time frame: At 3 months postoperatively

Observer Scar Assessment Scale (OSAS)

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).