Clinical trial

Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer

Recruiting now · Not applicable · 1 countries · Registry ID NCT05974995

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexFemale

Healthy volunteersNot accepted

ConditionEndometrial Cancer, Endometrial Neoplasms, Obesity, Morbid, Gynecologic Cancer, Gynecologic Disease

Full registry 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

Treatments and study arms

Robot-assisted surgery

Procedure

Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi

Laparoscopic surgery

Procedure

Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach

Primary outcomes

Conversion rateAt the end of the enrollment phase

Number of procedures converted to laparotomy from MIS

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Policlinico Gemelli IRCCS🇮🇹 Rome, Italy

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Francesco Fanfani, MdContact