Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy) (LPSvsLPT)

May 4, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy) : Multicenter Retrospective Observational Study

Since the publication of the LAP2 study, a prospective randomized trial, laparoscopy has been considered the gold standard for treating patients with early-stage endometrial cancer (EC). However, no prospective randomized trials have been published reporting comparable data in patients with EC at high risk of recurrence (advanced stages or non-endometrioid histology). Nonetheless, some retrospective studies and a systematic review of the literature have demonstrated that minimally invasive surgery achieves better perioperative outcomes than laparotomy without compromising survival in patients with EC at high risk of recurrence.

The aim of this multicenter retrospective observational study is to evaluate the safety of minimally invasive surgery in treating EC at low, intermediate, and high risk of recurrence according to the ESMO-ESGO classification, based on cases treated in hospitals within the Emilia Romagna region. Specifically, we aim to assess the effects of a minimally invasive surgical approach compared to laparotomy in terms of:

  1. Perioperative and postoperative complications: including the need for transfusions during and/or after surgery, duration of surgery, fever exceeding 38°C for more than 48 hours, and length of hospitalization.
  2. Long-term oncological outcomes: including overall survival, disease-free survival, recurrence rates, recurrence sites, and time to recurrence.

This comparison will include patients treated for both endometrioid and non-endometrioid EC to provide a comprehensive evaluation of minimally invasive surgery versus laparotomy.

By delineating the safety and efficacy of laparoscopic techniques, particularly for higher-risk patients, this research could refine surgical standards and guide clinical decision-making, emphasizing evidence-based practices for tailored patient care. The study also aligns with broader efforts to optimize cancer management in regional and national healthcare settings.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

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

Study Locations

  • Italy
      • Bologna, Italy
        • IRCCS - AOU Bologna
      • Bologna, Italy
        • Policlinico Sant'Orsola - Malpighi
      • Ferrara, Italy
        • Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara
      • Forlì, Italy
        • Ospedale Morgagni - Pierantoni
      • Modena, Italy, 41125
        • Policlinico di Modena
      • Parma, Italy
        • AOU Parma
      • Rimini, Italy
        • Ospedale di Rimini, AUSL Romagna
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Azienda USL IRCCS di Reggio Emilia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent laparoscopic or laparotomic surgery for Type I or Type II endometrial cancer in the Emilia-Romagna region between 2000 and 2020

Description

Inclusion Criteria:

  • Patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020

Exclusion Criteria:

  • Patients with other types of tumors (e.g., cervical or ovarian cancer).
  • Patients for whom surgical and/or post-operative data are unavailable.
  • Patients with a follow-up period of less than 6 months.
  • Patients who refuse to provide informed consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with endometrial cancer who underwent surgical treatment
All patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.
Procedure: Laparoscopy
Minimally invasive surgery
Procedure: Laparotomy
Open Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complications
Time Frame: 30 days post-surgery.
This metric assesses the number of participants with perioperative complications in the two intervention groups, specifically including the need for blood transfusions (either intraoperative or postoperative), surgery duration exceeding 180 minutes, postoperative fever >38°C lasting more than 48 hours, and hospitalization exceeding 7 days.
30 days post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Five years post-surgery (from the date of surgery up to 5 years)
Death from Any Cause
Five years post-surgery (from the date of surgery up to 5 years)
Disease-Free Survival (DFS)
Time Frame: Five years post-surgery (from the date of surgery up to 5 years)
Time from Surgery to First Disease Recurrence or Death
Five years post-surgery (from the date of surgery up to 5 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of recurrence
Time Frame: Five years post-surgery (from the date of surgery up to 5 years)
Evaluation of the sites of recurrence, including pelvic relapse, lymph node relapse, and distant metastasis, with documentation of the timing of occurrence
Five years post-surgery (from the date of surgery up to 5 years)
Complete Cytoreduction
Time Frame: Time of surgery
Assessment of complete surgical cytoreduction, defined as the absence of visible residual disease at the conclusion of surgery
Time of surgery

Collaborators and Investigators

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

Sponsor

Azienda USL Reggio Emilia - IRCCS

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)

May 10, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 519/2020/OSS/AUSLRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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