Laparotomy vs Laparoscopy in Endometrial Cancer Staging

June 6, 2026 updated by: AM Abdelbary, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is the most common gynecologic malignancy in developed countries, with increasing incidence related to obesity, aging, and metabolic disorders. Most patients present with early-stage disease confined to the uterus, making surgical staging the cornerstone of treatment. Standard management includes total hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node assessment when indicated for accurate staging and risk stratification . Minimally invasive surgery (MIS), particularly laparoscopy, has increasingly replaced laparotomy in the surgical staging of endometrial cancer because of its perioperative advantages. Previous studies demonstrated that laparoscopic surgery is associated with reduced blood loss, fewer postoperative complications, shorter hospital stay, and faster return to normal activity while maintaining comparable oncologic outcomes to open surgery. Recently, greater emphasis has been placed on patient-centered outcomes and enhanced recovery after surgery (ERAS) pathways. Early postoperative recovery is considered an important indicator of surgical quality and functional rehabilitation. Time to ambulation is a simple and clinically relevant marker of recovery, as delayed mobilization is associated with prolonged hospitalization and increased postoperative morbidity. Faster recovery may also facilitate earlier initiation of adjuvant therapy when indicated. Additionally, discrepancies between preoperative curettage pathology and final histopathology may alter risk stratification and postoperative management. Despite strong evidence supporting laparoscopy, most data originate from high-resource settings with advanced ERAS systems. Evidence from low-resource settings remains limited, particularly regarding functional recovery metrics, cost-effectiveness, and real-world delays in adjuvant therapy. Furthermore, few randomized trials have incorporated patient-reported recovery outcomes alongside oncologic endpoints.Therefore, this study aims to compare laparoscopic and open surgical staging for early-stage endometrial cancer regarding early postoperative recovery, perioperative outcomes, postoperative morbidity, delay in initiation of adjuvant therapy, and concordance between preoperative and final histopathological findings.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hisham El-Sayed Abou-Taleb, professor
  • Phone Number: +201003332139

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Laparoscopic surgical staging
surgical staging by laparoscopy
Procedure: laparoscopic surgical staging
surgical staging by laparoscopy
Other: Open surgical staging (laparotomy)
surgical staging by open surgery
Procedure: open surgical staging
surgical staging through open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From the end of surgery until the patient achieves independent ambulation or ambulation with minimal assistance, assessed during the first 24 postoperative hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Term Oncologic Outcomes
Time Frame: follow up for one year
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.
follow up for one year
Postoperative quality of recovery
Time Frame: at 12 hours, 24 hours, 48 hours postoperatively , and at time of hospital discharge (up to 5 postoperative days).
Postoperative quality of recovery assessed by the Quality Of Recovery -15 questionnaire (QoR-15 questionnaire) 0-150 130-150: Excellent recovery 122-129: Good recovery 90-121: Moderate recovery <90: Poor recovery / significant postoperative impairment
at 12 hours, 24 hours, 48 hours postoperatively , and at time of hospital discharge (up to 5 postoperative days).
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.
From the day of surgery through hospital discharge, assessed up to 7 days postoperatively.
comparsion between same day discgarge between laparoscopic and open surgical staging
Time Frame: Day 0 (day of surgery)
Day 0 (day of surgery)
Pelvic lymph node yield (number of nodes)
Time Frame: At final histopathological examination (within 2 weeks postoperatively)
Comparison of the total number of pelvic lymph nodes retrieved between laparoscopic and open surgical staging.
At final histopathological examination (within 2 weeks postoperatively)
Comparison of estimated blood loss during surgery between laparoscopic and open surgical staging.
Time Frame: During surgery (intraoperative period)
During surgery (intraoperative period)
Comparison of intraoperative complications between laparoscopic and open surgical staging.
Time Frame: During surgery
During surgery
Postoperative complications (Clavien-Dindo classification, Grades I-V)
Time Frame: Within 30 days after surgery
Comparison of the incidence and severity of postoperative complications between laparoscopic and open surgical staging. Complications will be graded according to the Clavien-Dindo classification, where Grade I represents minor deviation from normal postoperative course and Grade V represents death.
Within 30 days after surgery
comparsion of health-related quality of life assessed using the EQ-5D-5L questionnaire between open and laparoscopic surgical staging
Time Frame: baseline (preoperative), 6 weeks, and 12 weeks postoperatively.
baseline (preoperative), 6 weeks, and 12 weeks postoperatively.
hospital-based cost comparison between both surgical approaches
Time Frame: From surgery until hospital discharge, assessed up to 30 days postoperatively.
Hospital-based costs will include operating room time cost, surgical instruments and energy devices, hospital stay cost, and costs related to the management of postoperative complications occurring within 30 days after surgery.
From surgery until hospital discharge, assessed up to 30 days postoperatively.
Discrepancy between preoperative curettage pathology and final histopathology
Time Frame: From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.
Comparison of histological type, tumor grade, and disease characteristics between preoperative endometrial sampling pathology and the final postoperative histopathological diagnosis.
From preoperative endometrial sampling through final postoperative histopathological assessment, up to 30 days after surgery.
Conversion Rate
Time Frame: guring surgery
Rate and causes of conversion from laparoscopy to open surgery in the laparoscopic arm.
guring surgery
Delay in initiation of adjuvant therapy
Time Frame: Defined as the interval between date of surgery and initiation of adjuvant chemotherapy and/or radiotherapy. Delayed initiation will be considered when adjuvant treatment is started more than 6 weeks after surgery.
Defined as the interval between date of surgery and initiation of adjuvant chemotherapy and/or radiotherapy. Delayed initiation will be considered when adjuvant treatment is started more than 6 weeks after surgery.
Readmission within 6 weeks after surgery.
Time Frame: within 6 weeks postoperative
within 6 weeks postoperative
Total postoperative analgesic consumption during hospital stay.
Time Frame: "From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"
"From arrival at the recovery room until hospital discharge (up to 72 hours postoperatively)"
Time to bowel function recovery
Time Frame: From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.
From the end of surgery until first passage of flatus and stool, assessed up to 7 days postoperatively.
Time to oral intake
Time Frame: From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.
From the end of surgery until first tolerated oral intake, assessed up to 72 hours postoperatively.
Postoperative pain score using Visual Analogue Scale (VAS)
Time Frame: Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).
Time Frame: 6, 12, 24, and 48 hours postoperatively, and at hospital discharge (up to 7 days postoperatively).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EC-STAGE-LL-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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