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RECRUITING
NCT07546825
NA

Laparotomy vs Laparoscopy in Endometrial Cancer Staging

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Endometrial cancer is one of the most common gynecological malignancies worldwide. Surgical staging is the cornerstone of management and traditionally performed via laparotomy. However, minimally invasive surgery, particularly laparoscopy, has emerged as an effective alternative with potential benefits in reducing postoperative morbidity. This study aims to compare the outcomes of laparoscopic versus open (laparotomy) surgical staging in patients with endometrial cancer in low-resource settings. Primary aim: To compare early postoperative recovery after surgical staging for early-stage endometrial cancer between laparoscopic and open approaches, assessed primarily by time to ambulation. • Secondary aim: To compare intraoperative outcomes (operative time, blood loss, lymph node yield), postoperative morbidity (Clavien-Dindo classification), quality of recovery (QoR-15), length of hospital stay, same day discharge(SDD), discrepancy between preoperative curettage pathology and final histopathology, delay in initiation of adjuvant therapy, one-year disease-free survival, direct hospital costs between both approaches, and quality of life using EQ-5D-5L questionnaire. Given the limited resources and variations in surgical expertise in low-resource settings, this study seeks to evaluate the feasibility, safety, and effectiveness of laparoscopy compared to laparotomy. The findings may help guide clinical decision-making and optimize surgical approaches in similar healthcare environments.

Official title: Perioperative Outcomes of Surgical Staging in Patients With Early-stage Endometrial Carcinoma: Comparison Between Laparoscopy and Laparotomy in a Low-resource Setting

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-06-02

Completion Date

2028-10-01

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

PROCEDURE

laparoscopic surgical staging

surgical staging by laparoscopy

PROCEDURE

open surgical staging

surgical staging through open surgery

Locations (1)

Assiut University, Assiut,

Asyut, Egypt