Laparotomy vs Laparoscopy in Endometrial Cancer Staging

April 16, 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. The primary outcome will be comparison of operative time between laparoscopic and open pelvic lymphadenectomy. Secondary outcomes include intraoperative complications, intraoperative blood loss, hospital stay, recovery parameters, and oncological outcomes.

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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometrial Cancer is the most common gynecologic malignancy in developed countries, and its incidence continues to rise worldwide. The majority of patients present with early-stage disease due to symptoms such as abnormal uterine bleeding, which facilitates early diagnosis and treatment. Surgical management remains the cornerstone of therapy and typically includes total hysterectomy with bilateral salpingo-oophorectomy with or without lymph node assessment depending on the patient's risk factors and disease stage.

Pelvic lymphadenectomy plays an important role in accurate staging, prognostic stratification, and guiding decisions regarding adjuvant therapy. Traditionally, surgical staging was performed through open laparotomy, which provides adequate exposure for lymph node dissection. However, open surgery is associated with significant perioperative morbidity, including increased blood loss, postoperative pain, longer hospital stay, and higher rates of wound complications .

Minimally invasive surgery has increasingly been adopted in gynecologic oncology as an alternative to open surgery. Laparoscopic approaches offer several advantages, including improved visualization of anatomical structures, reduced intraoperative blood loss, faster recovery, and shorter hospitalization. Several studies have evaluated the feasibility and safety of laparoscopic surgical staging in endometrial cancer. In addition to the conventional transperitoneal approach, laparoscopic extraperitoneal lymphadenectomy has emerged as an alternative technique that avoids peritoneal entry and may offer advantages in selected patients, particularly those with obesity or extensive intra-abdominal adhesions. However, extraperitoneal lymphadenectomy is technically demanding, requires advanced spatial orientation .

The oncologic safety of minimally invasive surgical staging has been demonstrated in the randomized LAP2 Trial, which showed comparable recurrence and survival outcomes between laparoscopic and open surgical staging while providing improved perioperative outcomes for laparoscopy.

Recent advances in molecular pathology have introduced a molecular classification system for endometrial cancer based on genomic analysis described by The Cancer Genome Atlas (TCGA). This classification divides tumors into four main molecular subgroups: POLE ultramutated, microsatellite instability or mismatch repair deficient (MMRd), copy-number low (p53 wild-type), and copy-number high (p53 abnormal). Molecular classification provides significant prognostic information and has been incorporated into modern risk-stratification systems to guide adjuvant therapy and surgical decision-making in endometrial cancer.

Therefore, this study hypothesizes that laparoscopic pelvic lymphadenectomy provides superior perioperative outcomes while maintaining comparable oncologic safety compared with open pelvic lymphadenectomy in patients with endometrial cancer in low-resource settings.

Study Type

Interventional

Enrollment (Estimated)

116

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

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 (7).
  • Planned surgical staging including: total hysterectomy, bilateral salpingo-oophorectomy and pelvic lymphadenectomy.
  • good performance status : ECOG 0, 1, 2

  • patients who provide informed written consent to participate in the study.

    b. 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 pelvic lymphadenectomy
pelvic lymphadenectomy by laparoscopy
Procedure: laparoscopic pelvic lymphadenectomy
pelvic lymphadenectomy by laparoscopy
Other: Open pelvic lymphadenectomy (laparotomy)
pelvic lymphadenectomy by open surgery
Procedure: open pelvic lymphadenectomy
pelvic lymphadenevtomy through open surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of total operative time between laparoscopic and open pelvic lymphadenectomy.
Time Frame: during surgery
from identification of pelvic landmarks to completion of lymph node dissection
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of hospital stay duration between laparoscopic and open lymphadenectomy.
Time Frame: from day of surgery until discharge (days)
from day of surgery until discharge (days)
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 pelvic lymphadenectomy.
At final histopathological examination (within 2 weeks postoperatively)
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 estimated blood loss during surgery between laparoscopic and open lymphadenectomy.
Time Frame: During surgery (intraoperative period)
During surgery (intraoperative period)
Comparison of intraoperative complications between laparoscopic and open lymphadenectomy.
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 pelvic lymphadenectomy. 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

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 (Estimated)

May 1, 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)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 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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