NCT07725159

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 21, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Endometrial cancerLaparoscopyLee-Huang pointUmbilical entryRandomized controlled trial

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

EXPERIMENTAL

Laparoscopic abdominal entry using the Lee-Huang point

Procedure: Laparoscopic entry through the Lee-Huang point

Umbilical Entry

ACTIVE COMPARATOR

Standard laparoscopic abdominal entry through the umbilicus

Procedure: Standart umbilical laparoscopic entry

Interventions

Initial laparoscopic abdominal entry was performed by direct tracar insertion through the Lee-Huang point

Lee-Huang Point

Initial laparoscopic abdominal entry was performed by direct trocar insertion through the umbilicus.

Umbilical Entry

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Murat Api, MD

    University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital

    PRINCIPAL INVESTIGATOR

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

Locations