NCT06790004Active, not recruiting
Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy)
Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy) : Multicenter Retrospective Observational Study
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 16 Jan 2025
- Start date
- 10 May 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Diseases
- Endometrial cancer
- NCT number
- NCT06790004
What you commit to
- Study type: Observational
- Planned participants: 700
- From 10 May 2021 to the primary completion date, 31 Dec 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients for whom surgical and/or post-operative data are unavailable.
Other illness
- Patients with other types of tumors (e.g., cervical or ovarian cancer).
Other
- Patients with a follow-up period of less than 6 months.
- Patients who refuse to provide informed consent.
Who the study is looking for
- Patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| IRCCS - AOU Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale Morgagni - Pierantoni Coordinator of this site? Confirm its status | Forlì | Italy | Unknown status |
| Policlinico di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| AOU Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
| Ospedale di Rimini, AUSL Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.