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Recruiting Not applicable

Laparotomy vs Laparoscopy in Endometrial Cancer Staging

NCT07546825 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-06-02
Last updated
2026-06-10

Condition(s) studied

Gynaecological OncologyGynaecological MalignanciesLaparoscopic

Investigational drug(s) / intervention(s)

laparoscopic surgical stagingopen surgical staging

laparoscopic surgical staging: surgical staging by laparoscopy

open surgical staging: surgical staging through open surgery

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
1. Inclusion criteria: * Histologically confirmed endometrial carcinoma, diagnosed by endometrial biopsy or dilatation and curettage. * patient candidate for pelvic lymphadenectomy according to risk stratification in endometrial cancer according to ESGO/ESTRO/ESP, 2021 (6). * Planned surgical staging including: total hysterectomy, bilateral salpingo-oophorectomy ± pelvic lymphadenectomy. * good performance status : ECOG 0, 1, 2 * patients who provide informed written consent to participate in the study. 2. Exclusion criteria: * severe cardiopulmonary diseases (e.g unstable angina, severe COPD). * Absolute contraindication to laparoscopy. * stage Ⅲ and Ⅳ endometrial cancer. * patients who received previous pelvic radiotherapy. * patients who underwent prior lymphadenectomy.

Primary outcome measure(s)

  • Early postoperative recovery assessed by time to ambulation (hours). — From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.

Trial sites (1)

FacilityCityRegionStatus
Assiut University, Assiut, Asyut Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07546825 on ClinicalTrials.gov ↗ ← All trials in Egypt