Endometrial Cancer
Conditions
Keywords
Endometrial cancer, Laparoscopy, Lee-Huang point, Umbilical entry, Randomized controlled trial
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.
Detailed description
This single-center prospective randomized controlled trial was conducted at the Department of Gynecologic Oncology, Kartal Dr. Lutfi Kirdar City Hospital, University of Health Sciences Turkey. Eligible patients with endometrial cancer scheduled for laparoscopic surgical staging were randomly assigned to either Lee-Huang point entry or conventional umbilical entry. The primary objective was to compare successful abdominal access and entry-related complications between the two techniques. Secondary outcomes included operative time, blood loss, conversion to laparotomy, intraoperative and postoperative complications, and other perioperative outcomes. A total of 202 patients completed the study.
Interventions
PROCEDURELaparoscopic entry through the Lee-Huang point
Initial laparoscopic abdominal entry was performed by direct tracar insertion through the Lee-Huang point
PROCEDUREStandart umbilical laparoscopic entry
Initial laparoscopic abdominal entry was performed by direct trocar insertion through the umbilicus.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful laparoscopic abdominal entry | During surgery | Successful intraperitoneal access through the assigned entry site using direct trocar insertion without the need for conversion to another abdominal entry technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Entry-related complications | During surgery | Incidence of bowel injury, vascular injury, and other complications related to direct trocar insertion through the assigned entry site. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMurat Api, MD
University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital
Outcome results
None listed