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

NCT06790004 | Active Not Recruiting

• 1 other identifier: 519/2020/OSS/AUSLRE
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 8

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. 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. 2.Long-term oncological outcomes: including overall survival, disease-free survival, recurrence rates, recurrence sites, and time to recurrence.

Conditions

Endometrial Carcinoma

Keywords

endometrial cancer; laparoscopy; laparotomy; minimally invasive surgery; risk of recurrence; Surgical complications

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post-surgery.

Secondary Outcomes (2)

• Overall Survival (OS)

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

• Disease-Free Survival (DFS)

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

Other Outcomes (2)

• Pattern of recurrence

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

• Complete Cytoreduction

  Time of surgery

Study Arms (1)

Patients with endometrial cancer who underwent surgical treatment

All patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.

Procedure: Laparotomy; Procedure: Laparoscopy

Interventions

Laparotomy PROCEDURE

Open Surgery

Patients with endometrial cancer who underwent surgical treatment

Laparoscopy PROCEDURE

Minimally invasive surgery

Patients with endometrial cancer who underwent surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals assigned female at birth are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with a diagnosis of endometrial cancer who underwent surgical treatment between 2000 and 2020

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (8)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

IRCCS - AOU Bologna

Bologna, Italy

Location

Policlinico Sant'Orsola - Malpighi

Bologna, Italy

Location

Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara

Ferrara, Italy

Location

Ospedale Morgagni - Pierantoni

Forlì, Italy

Location

Policlinico di Modena

Modena, 41125, Italy

Location

AOU Parma

Parma, Italy

Location

Ospedale di Rimini, AUSL Romagna

Rimini, Italy

Location

Related Publications (12)

• AIRTUM Working Group. I numeri del cancro in Italia 2015. http://www.registotumori.it/PDF/AIOM2015/I-numeri_del_cancro_2015.pd

  BACKGROUND

• Papathemelis 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 BACKGROUND

• Melamed 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 BACKGROUND

• Ramirez 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 BACKGROUND

• Scaletta 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 BACKGROUND

• Papadia 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.

  PMID: 31781888 BACKGROUND

• Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.

  PMID: 19805679 BACKGROUND

• Safdieh J, Lee YC, Wong A, Lee A, Weiner JP, Schwartz D, Schreiber D. A Comparison of Outcomes Between Open Hysterectomy and Robotic-Assisted Hysterectomy for Endometrial Cancer Using the National Cancer Database. Int J Gynecol Cancer. 2017 Sep;27(7):1508-1516. doi: 10.1097/IGC.0000000000001034.

  PMID: 29470186 BACKGROUND

• Mourits MJ, Bijen CB, Arts HJ, ter Brugge HG, van der Sijde R, Paulsen L, Wijma J, Bongers MY, Post WJ, van der Zee AG, de Bock GH. Safety of laparoscopy versus laparotomy in early-stage endometrial cancer: a randomised trial. Lancet Oncol. 2010 Aug;11(8):763-71. doi: 10.1016/S1470-2045(10)70143-1. Epub 2010 Jul 16.

  PMID: 20638901 BACKGROUND

• Ferguson SE, Panzarella T, Lau S, Gien LT, Samouelian V, Giede C, Steed H, Le T, Renkosinski B, Bernardini MQ. Prospective cohort study comparing quality of life and sexual health outcomes between women undergoing robotic, laparoscopic and open surgery for endometrial cancer. Gynecol Oncol. 2018 Jun;149(3):476-483. doi: 10.1016/j.ygyno.2018.04.558. Epub 2018 Apr 19.

  PMID: 29681461 BACKGROUND

• Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

  PMID: 23636398 BACKGROUND

• Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

  PMID: 23485231 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Laparotomy; Laparoscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 23, 2025
• Study Start: May 10, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)