Clinical trial · Interventional
A Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
A Single Center, Randomized, Single Blind, Parallel Controlled Clinical Study Comparing the Effectiveness and Safety of Two Surgical Pathways for Laparoscopic Total Hysterectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Tumor of Uterus | Benign Uterine Neoplasm | ALIAS | 0.90 |
| Enhanced Recovery After Surgery | — | UNRESOLVED | — |
| Surgical Approaches | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-Port Laparoscopic Surgery | Procedure | — | UNRESOLVED |
| Transumbilical Laparoendoscopic Single-Site Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transumbilical Laparoendoscopic Single-Site Surgery (TU-LESS) Group
- description
- 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.
- interventionNames
- Procedure: Transumbilical Laparoendoscopic Single-Site Surgery
- type
- ACTIVE_COMPARATOR
- label
- Multi-Port Laparoscopic Surgery (MPLS) Group
- description
- 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.
- interventionNames
- Procedure: Multi-Port Laparoscopic Surgery
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available