Clinical trial NCT06790004: Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy)
Official title: Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy vs Laparotomy) : Multicenter Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Carcinoma
Keywords: endometrial cancer
laparoscopy
laparotomy
minimally invasive surgery
risk of recurrence
Surgical complications
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2025-01-23
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative Complications
timeFrame: 30 days post-surgery.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Five years post-surgery (from the date of surgery up to 5 years)
measure: Disease-Free Survival (DFS)
timeFrame: Five years post-surgery (from the date of surgery up to 5 years)
Other outcomes:
measure: Pattern of recurrence
timeFrame: Five years post-surgery (from the date of surgery up to 5 years)
measure: Complete Cytoreduction
timeFrame: Time of surgery
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
state: RE
city: Bologna
country: Italy
facility: IRCCS - AOU Bologna
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola - Malpighi
city: Ferrara
country: Italy
facility: Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara
city: Forlì
country: Italy
facility: Ospedale Morgagni - Pierantoni
city: Modena
country: Italy
facility: Policlinico di Modena
city: Parma
country: Italy
facility: AOU Parma
city: Rimini
country: Italy
facility: Ospedale di Rimini, AUSL Romagna
Study officials:
References:
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