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Endometrial CarcinomaLPSvsLPTNCT06790004

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

An observational study of Endometrial Carcinoma, run by Azienda USL Reggio Emilia - IRCCS at 8 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Carcinoma
What is being tested?
Laparotomy and Laparoscopy
Type of treatment
Surgery or procedure
How many people
700 participants
Where
8 sitesItaly
Study dates
10 May 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • IRCCS - AOU Bologna

    Bologna

  • Policlinico Sant'Orsola - Malpighi

    Bologna

  • Azienda Ospedaliera- Universitaria Arcispedale Sant'Anna Ferrara

    Ferrara

  • Ospedale Morgagni - Pierantoni

    Forlì

  • Policlinico di Modena

    Modena, 41125

  • AOU Parma

    Parma

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, RE, 42123

  • Ospedale di Rimini, AUSL Romagna

    Rimini

Other trials in Italy

About this study

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

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:

Read more
  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.

Being tested
Laparotomy, Laparoscopy
Keywords
endometrial cancer, laparoscopy, laparotomy, minimally invasive surgery, risk of recurrence, Surgical complications
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaparotomyProcedure or surgery

    Open Surgery

  • LaparoscopyProcedure or surgery

    Minimally invasive surgery

Study groups in NCT06790004
Study groupRoleWhat they receive
Patients with endometrial cancer who underwent surgical treatmentAll patients with endometrial cancer who underwent surgical treatment from 2000 to 2020 at all participating centers in Emilia-Romagna.
Receives: Procedure: Laparotomy; Procedure: Laparoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days post-surgery.

Secondary outcomes (2)

  1. Overall Survival (OS)

    Death from Any Cause

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

  2. Disease-Free Survival (DFS)

    Time from Surgery to First Disease Recurrence or Death

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start10 May 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790004
Sponsor's protocol ID
519/2020/OSS/AUSLRE
Acronym
LPSvsLPT
Status last verified
May 2026
First submitted
16 Jan 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 31901975

  • 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.

    PubMed 30379613

  • 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.

    PubMed 30380365

  • 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.

    PubMed 31818527

  • 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.

    PubMed 31781888

  • 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.

    PubMed 19805679

  • 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.

    PubMed 29470186

  • 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.

    PubMed 20638901

  • 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.

    PubMed 29681461

  • 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.

    PubMed 23636398

  • 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.

    PubMed 23485231

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Carcinoma, run by Azienda USL Reggio Emilia - IRCCS at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative Complications (time frame: 30 days post-surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790004, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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