About this trial
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
This trial does not accept healthy volunteersQualifiers
BMI >=30
Age > 18
Histologically confirmed endometrioid endometrial cancer
Clinical early stage (stage I)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Robot-assisted surgery
Procedure/SurgeryTotal hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi
Laparoscopic surgery
Procedure/SurgeryTotal hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach
Treatment groups
Trial outcomes
Primary outcomes
Conversion rate
Number of procedures converted to laparotomy from MIS
Secondary outcomes
Difference in overall duration of surgery
Difference in duration of procedures measured in minutes
Difference in perioperative complications
Number of patients with at least one perioperative complications measured by Clavien Dindo
Adherence to sentinel lymph node MSKCC algorithm
Number of case with completed lymph nodal staging according to MSKCC algorithm
Ergonomics of the two different surgical approach
Investigators will evaluate the ergonomics of the two MIS system through the Rapid Upper Limb Assessment (RULA) assessment tool. Rula is aimed to make a rapid assessment on neck and upper limb loading in tasks. The risk of work-related disorders is calculated into a score of 1(low) to 7 (high)
Sponsors and contacts
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