NCT05974995 Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
| NCT ID | NCT05974995 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 566 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 566 participants in total. It began in 2023-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * High probability of laparotomy related to uterine volume (US estimated weight \>250 g) * Concomitant pelvic disease, or anatomical characteristics of the patient * (Use of uterine manipulator) * Age \>75 years
Contact & Investigator
Francesco Fanfani, MD
PRINCIPAL INVESTIGATOR
Policlinico Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT05974995 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974995 currently recruiting?
Yes, NCT05974995 is actively recruiting participants. Contact the research team at francesco.fanfani@policlinicogemelli.it for enrollment information.
Where is the NCT05974995 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05974995 clinical trial?
NCT05974995 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Francesco Fanfani, MD at Policlinico Gemelli IRCCS. The trial plans to enroll 566 participants.
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