Laparotomy vs Laparoscopy in Endometrial Cancer Staging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAssiut University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
laparoscopic surgical staging
Procedure/Surgerysurgical staging by laparoscopy
open surgical staging
Procedure/Surgerysurgical staging through open surgery
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic surgical stagingOther 1 intervention
Group B: Open surgical staging (laparotomy)Other 1 intervention
Trial outcomes
Primary outcomes
1
Early postoperative recovery assessed by time to ambulation (hours).
Time frame
From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.Secondary outcomes
1
Comparison of hospital stay duration between laparoscopic and open surgical staging
Time frame
From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.2
comparsion between same day discgarge between laparoscopic and open surgical staging
Time frame
Day 0 (day of surgery)3
Pelvic lymph node yield (number of nodes)
Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging.
Time frame
At final histopathological examination (within 2 weeks postoperatively)4
Short-Term Oncologic Outcomes
One-year disease-free survival (DFS), defined as the time from surgery to first documented recurrence (local, regional, or distant) or death from any cause.
Time frame
follow up for one yearSponsors and contacts
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Source ClinicalTrials.gov