Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06790004

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, RE, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparotomy

Procedure

Open Surgery

Laparoscopy

Procedure

Minimally invasive surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Five years post-surgery (from the date of surgery up to 5 years)

    Death from Any Cause

  2. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: LPSvsLPT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.