Comparison of Lee-Huang Point and Umbilical Entry for Laparoscopic Success in Endometrial Cancer Patients
LEAP
1 other identifier
interventional
202
1 country
1
Brief Summary
This randomized controlled trial compares Lee-Huang point entry with conventional umbilical entry for laparoscopic surgery in patients with endometrial cancer. The study aims to evaluate the success of abdominal entry, entry-related complications, operative outcomes, and perioperative safety. A total of 202 patients were randomized to either the Lee-Huang entry group or the umbilical entry group and underwent laparoscopic surgical staging. The findings are expected to provide evidence regarding the optimal primary entry technique for laparoscopic management of endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 24, 2026
CompletedJuly 27, 2026
July 1, 2026
2 years
July 21, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful laparoscopic abdominal entry
Successful intraperitoneal access through the assigned entry site using direct trocar insertion without the need for conversion to another abdominal entry technique.
During surgery
Secondary Outcomes (1)
Entry-related complications
During surgery
Study Arms (2)
Lee-Huang Point
EXPERIMENTALLaparoscopic abdominal entry using the Lee-Huang point
Umbilical Entry
ACTIVE COMPARATORStandard laparoscopic abdominal entry through the umbilicus
Interventions
Initial laparoscopic abdominal entry was performed by direct tracar insertion through the Lee-Huang point
Initial laparoscopic abdominal entry was performed by direct trocar insertion through the umbilicus.
Eligibility Criteria
You may qualify if:
- Female patients aged 18 years or older.
- Scheduled for elective laparoscopic gynecologic surgery.
- Eligible for laparoscopic abdominal entry through either the Lee-Huang point or the umbilical entry site.
- Provided written informed consent.
You may not qualify if:
- Pregnancy.
- Emergency surgery.
- Previous upper abdominal surgery precluding safe Lee-Huang point or umbilical entry.
- Contraindication to laparoscopy.
- Refusal or inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul, 34865, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murat Api, MD
University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gynecologic Oncology Fellow
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 24, 2026
Study Start
April 28, 2024
Primary Completion
April 28, 2026
Study Completion
April 28, 2026
Last Updated
July 27, 2026
Record last verified: 2026-07