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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Robot-assisted surgery

    Procedure/Surgery

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

  • Laparoscopic surgery

    Procedure/Surgery

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

Treatment groups

566 Participants
are divided into 2 treatment groups
Group A: Robotic surgeryExperimental treatment 1 intervention
Group B: Laparoscopic surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Conversion rate

Number of procedures converted to laparotomy from MIS

Time frame
At the end of the enrollment phase

Secondary outcomes

1

Difference in overall duration of surgery

Difference in duration of procedures measured in minutes

Time frame
At the end of the enrollment phase
2

Difference in perioperative complications

Number of patients with at least one perioperative complications measured by Clavien Dindo

Time frame
36 and 72 months
3

Adherence to sentinel lymph node MSKCC algorithm

Number of case with completed lymph nodal staging according to MSKCC algorithm

Time frame
At the end of the enrollment phase
4

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)

Time frame
At the end of the enrollment phase

Other outcomes

Sponsors and contacts

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