Benign Tumor of Uterus, Enhanced Recovery After Surgery, Surgical Approaches
Conditions
Keywords
hysterectomy, single-port, multi-port, enhanced recovery after surgery
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.
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.
Interventions
PROCEDURETransumbilical Laparoendoscopic Single-Site Surgery
Total hysterectomy performed through a single incision made at the umbilicus, using specialized single-port access devices.
PROCEDUREMulti-Port Laparoscopic Surgery
Total hysterectomy performed through 3 to 4 small incisions in the abdomen, using conventional laparoscopic instruments and ports.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive ERAS Achievement Rate at 24 Hours Postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hemoglobin Level | Postoperative Day 1 | Hemoglobin concentration measured on the first postoperative morning (Day 1). |
| Hemoglobin Decrease | From baseline to Postoperative Day 1 | Calculated as preoperative hemoglobin minus postoperative Day 1 hemoglobin. |
| Estimated Blood Loss (EBL) | Intraoperative | Intraoperative blood loss volume estimated by the attending surgeon. |
| Blood Transfusion Rate | Intraoperative to 7 days postoperatively | Proportion of patients receiving allogeneic or autologous blood transfusion during or after surgery. |
| Time to First Flatus | From end of surgery to event (within 7 days) | Time interval from the end of surgery to the first passage of flatus. |
| Rate of successful voiding following urinary catheter removal | From catheter removal to event (within 7 days) | Rate of successful voiding following urinary catheter removal |
| 24-Hour Postoperative VAS Pain Score | 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. |
| Patient Scar Assessment Scale (PSAS) | 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). |
| Observer Scar Assessment Scale (OSAS) | 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). |
Countries
China
Outcome results
None listed