NCT05974995Recruiting
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
Robotic-assisted Versus Conventional Laparoscopic Surgery in the Management of Obese Patients With Early Endometrial Cancer in the Sentinel Lymph Node Era: a Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 3 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI \>= 30) patients with endometrial carcinoma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 566 (estimated)
- First submitted
- 18 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Obesity, Endometrial cancer
- NCT number
- NCT05974995
What you commit to
- Study type: Interventional
- Planned participants: 566
- From 1 Sept 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant pelvic disease, or anatomical characteristics of the patient
Age
- Age \>75 years
Other
- High probability of laparotomy related to uterine volume (US estimated weight \>250 g)
- (Use of uterine manipulator)
Who the study is looking for
- BMI \>=30
- Age \> 18
- Histologically confirmed endometrioid endometrial cancer
- Clinical early stage (stage I)
- No contraindication for minimally invasive surgery
- ASA\<4
- Written informed consent.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.