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

NCT06790004Active, Not RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Azienda USL Reggio Emilia - IRCCS

Enrollment

700

Start Date

2021-05-10

Completion Date

2026-02-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

LaparotomyLaparoscopy

Conditions

Endometrial Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Perioperative Complications

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.

Time frame: 30 days post-surgery.

Secondary Outcomes

Overall Survival (OS)

Death from Any Cause

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

Disease-Free Survival (DFS)

Time from Surgery to First Disease Recurrence or Death

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

Locations

Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy

IRCCS - AOU Bologna, Bologna, Italy

Policlinico Sant'Orsola - Malpighi, Bologna, Italy

Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara, Ferrara, Italy

Ospedale Morgagni - Pierantoni, Forlì, Italy

Policlinico di Modena, Modena, Italy

AOU Parma, Parma, Italy

Ospedale di Rimini, AUSL Romagna, Rimini, Italy

Linked Papers

2020-01-04

Long-term outcome of patients with intermediate- and high-risk endometrial cancer after pelvic and paraaortic lymph node dissection: a comparison of laparoscopic vs. open procedure

The primary therapy for intermediate- and high-risk endometrial cancer includes pelvic and paraaortic lymph node evaluation. Laparoscopic surgery is an increasingly popular intervention due to decreased risk and better short-term morbidity; however, a recent study casts doubt on the benefit of this approach in terms of oncological safety. In this cancer registry study, we sought to evaluate the benefit of laparoscopy versus laparotomy and retrospectively compared overall survival, recurrence rates, and recurrence-free survival among patients with intermediate- and high-risk endometrial cancer who underwent either laparoscopic or open surgery. This observational study included 419 patients who have been treated from 2011 to 2017. We employed Kaplan-Meier method, and univariable and multivariable Cox-regression to compare overall survival, recurrence rates, and recurrence-free survival in 110 patients, who underwent laparoscopic, with 309 patients, who underwent open surgery. To address the confounding bias in this retrospective study, we also performed a propensity score matching (PSM) analysis including 357 patients (laparoscopy: n = 107; open surgery: n = 250). We found a benefit for laparoscopic over open surgery in patients with intermediate- and high-risk endometrial cancer for overall survival in both univariable (p = 0.002; PSM: p = 0.016) and multivariable analyses (p = 0.019; PSM: p = 0.007). In contrast, there was no statistically significant difference between both patient groups regarding the cumulative recurrence rates. A univariable analysis identified a significant benefit for laparoscopy regarding recurrence-free survival (p = 0.003; PSM: p = 0.029) but a multivariable analysis failed to confirm this finding (p = 0.108; PSM: p = 0.118). Our study provides evidence that laparoscopic systematic lymphadenectomy does not present a lower oncological efficacy than open surgery in the treatment of patients with endometrial cancer.

2019-12-02

Comparison of minimally invasive surgery with laparotomic approach in the treatment of high risk endometrial cancer: A systematic review

To analyze all published studies comparing minimally invasive surgery (MIS) with laparotomic one in the surgical treatment of high-risk endometrial cancer (EC) in term of operative, peri-operative and oncological outcomes. We conducted a systematic literature search in PubMed between January 1995-March 2019. Titles and abstracts were analyzed by two reviewers. A set of explicit criteria was used for selection of literature: 1) randomized controlled trials (RCT), prospective or retrospective cohort studies, given the rarity of this tumor and the concomitant lack of data in the form of large trials, all reviewed original report publications with an appropriate number of subjects were considered and included; 2) participants of interest being patients who have suffered from high risk EC 3) the outcome measures including overall survival (OS), disease-free survival (DFS) and recurrence, (4) English language, (5) abstract available. Thirty relevant articles were selected for full reading. For final analysis 20 studies were selected. Then, as second step, the full articles were evaluated to determine whether full inclusion criteria were met. In total, 9 papers were identified and included. MIS appears to be safe in the management of high-risk EC patients, showing better perioperative and postoperative outcomes and comparable oncological outcomes than open surgery. Prospective randomized trial would be needed to confirm this data.

2019-11-28

Minimally invasive surgery does not impair overall survival in stage IIIC endometrial cancer patients

We aimed to evaluate weather survival is impaired in stage IIIC endometrial cancer patients treated with minimally invasive surgery as compared to laparotomy. We analyzed surgical data and oncologic outcome of histologically proven stage IIIC endometrial cancer patients who were treated at our institution via laparotomy or via laparoscopic surgery. All the patients underwent a systematic pelvic and para-aortic lymphadenectomy and a complete tumor resection. Perioperative morbidity and overall survival of the patients subjected to the two surgical approaches were compared. Sixty-six patients with stage IIIC endometrial cancer were identified. Of these, 15 patients were operated via laparotomy and 51 via laparoscopy. The two groups were similar with regards to median age at diagnosis, BMI, histotype, number of affected lymph nodes, and median maximal diameter of the affected lymph nodes. Patients undergoing laparoscopic surgery had fewer perioperative complications, a smaller estimated blood loss, and were subjected less frequently to transfusions. Overall survival at 60 months of follow-up did not differ between the two groups. At uni- and multivariate analysis, surgical approach did not affect survival. Only age was a variable associated with overall survival. Minimally invasive surgery has better perioperative outcomes and does not impair survival in stage IIIC endometrial cancer patients. Age at diagnosis is the only factor independently affecting survival.

Linked Investigators

Andrea Papadia

Thomas Papathemelis