Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopy | Procedure | — | UNRESOLVED |
| Laparotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with endometrial cancer who underwent surgical treatment
- description
- All patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.
- interventionNames
- Procedure: Laparotomy
- Procedure: Laparoscopy
Primary outcomes (1)
- measure
- Perioperative Complications
- timeFrame
- 30 days post-surgery.
- description
- 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 (2)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDAIRTUM Working Group. I numeri del cancro in Italia 2015. http://www.registotumori.it/PDF/AIOM2015/I-numeri_del_cancro_2015.pd
- BACKGROUNDPapathemelis T, Oppermann H, Grafl S, Gerken M, Pauer A, Scharl S, Scharl A, Inwald E, Ignatov A, Ortmann O, Klinkhammer-Schalke M, Hein A, Beckmann MW, Lux MP. 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. J Cancer Res Clin Oncol. 2020 Apr;146(4):961-969. doi: 10.1007/s00432-019-03122-8. Epub 2020 Jan 4. PMID 31901975
- BACKGROUNDMelamed A, Margul DJ, Chen L, Keating NL, Del Carmen MG, Yang J, Seagle BL, Alexander A, Barber EL, Rice LW, Wright JD, Kocherginsky M, Shahabi S, Rauh-Hain JA. Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1905-1914. doi: 10.1056/NEJMoa1804923. Epub 2018 Oct 31. PMID 30379613
- BACKGROUNDRamirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31. PMID 30380365
- BACKGROUNDScaletta G, Dinoi G, Capozzi V, Cianci S, Pelligra S, Ergasti R, Fagotti A, Scambia G, Fanfani F. Comparison of minimally invasive surgery with laparotomic approach in the treatment of high risk endometrial cancer: A systematic review. Eur J Surg Oncol. 2020 May;46(5):782-788. doi: 10.1016/j.ejso.2019.11.519. Epub 2019 Dec 2. PMID 31818527
- BACKGROUNDPapadia A, Garbade A, Gasparri ML, Wang J, Radan AP, Mueller MD. Minimally invasive surgery does not impair overall survival in stage IIIC endometrial cancer patients. Arch Gynecol Obstet. 2020 Feb;301(2):585-590. doi: 10.1007/s00404-019-05393-5. Epub 2019 Nov 28.