Comparing surgical methods for endometrial cancer treatment
Endometrial Carcinoma: Comparison of Surgical Approaches (Laparoscopy Vs Laparotomy) : Multicenter Retrospective Observational Study
Azienda USL Reggio Emilia - IRCCS · NCT06790004
This study is testing whether minimally invasive surgery is safer and more effective than traditional surgery for treating endometrial cancer in patients with different risk levels of recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Azienda USL Reggio Emilia - IRCCS (other gov) |
| Locations | 8 sites (Reggio Emilia, RE and 7 other locations) |
| Trial ID | NCT06790004 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of minimally invasive surgery, specifically laparoscopy, compared to traditional laparotomy in treating patients with endometrial carcinoma. It focuses on patients at low, intermediate, and high risk of recurrence, based on the ESMO-ESGO classification. The study will analyze surgical outcomes from cases treated in hospitals across the Emilia Romagna region, utilizing data from surgeries performed between 2000 and 2020.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with endometrial cancer who underwent surgical treatment between 2000 and 2020.
Not a fit: Patients with other types of tumors or those lacking sufficient surgical data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer surgical options for patients with endometrial cancer, potentially improving recovery times and outcomes.
How similar studies have performed: Previous studies have shown that minimally invasive surgery can lead to better perioperative outcomes without compromising survival, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Reggio Emilia, RE and 7 other locations
- Azienda USL IRCCS di Reggio Emilia — Reggio Emilia, RE, Italy (RECRUITING)
- IRCCS - AOU Bologna — Bologna, Italy (COMPLETED)
- Policlinico Sant'Orsola - Malpighi — Bologna, Italy (COMPLETED)
- Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara — Ferrara, Italy (COMPLETED)
- Ospedale Morgagni - Pierantoni — Forlì, Italy (COMPLETED)
- Policlinico di Modena — Modena, Italy (COMPLETED)
- AOU Parma — Parma, Italy (COMPLETED)
- Ospedale di Rimini, AUSL Romagna — Rimini, Italy (COMPLETED)
Study contacts
- Study coordinator: Vincenzo Dario Mandato, MD
- Email: vincenzodario.mandato@ausl.re.it
- Phone: +39 0522 295467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Carcinoma, endometrial cancer, laparoscopy, laparotomy, minimally invasive surgery, risk of recurrence, Surgical complications