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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 566
- Locations
- 1
- Primary Endpoint
- Conversion rate
Study Overview
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.
Detailed Description
Background:
Endometrial cancer is the fourth cancer in women, the most common gynecologic cancer in high-income countries and the second most common gynecologic cancer worldwide.
The high incidence of endometrial cancer is associated with several risk factors, but the growing prevalence of obesity has been identified as one of the majors. Many patients with endometrial cancer are obese and have clinically relevant coexisting conditions that negatively affects anesthesiological parameters and surgical performance when patients undergo surgery, thus potentially increasing the risk of peri-operative complications.
For patients presenting at early-stage disease the standard procedure is total hysterectomy with bilateral salpingo-oophorectomy and lymph nodal staging. Prospective and retrospective studies demonstrate that compared to systemic lymphadenectomy, sentinel lymph node mapping have high accuracy in detecting nodal metastases, and together with ultrastaging may increase the detection of lymph node metastasis with low false-negative rates in patients with apparent uterine-confined disease. Also, recent evidence proved sentinel lymph node biopsy to be a feasible and safe alternative to lymphadenectomy in high-risk endometrial cancer.
Many randomized prospective studies proved laparoscopic surgical staging to be feasible in terms of short-term outcomes, equivalent in disease-free survival and no different in overall survival, thus the current surgical approach is minimally invasive. Also, innovative surgical approaches such as robotic surgery have been exploited showing equivalent oncologic outcomes when compared to traditional laparoscopic surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI >=30
- •Age > 18
- •Histologically confirmed endometrioid endometrial cancer
- •Clinical early stage (stage I)
- •No contraindication for minimally invasive surgery
- •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
Arms & Interventions
Robotic surgery
Intervention: Robot-assisted surgery (Procedure)
Laparoscopic surgery
Intervention: Laparoscopic surgery (Procedure)
Outcomes
Primary Outcomes
Conversion rate
Time Frame: At the end of the enrollment phase
Number of procedures converted to laparotomy from MIS
Secondary Outcomes
- Difference in overall duration of surgery(At the end of the enrollment phase)
- Adherence to sentinel lymph node MSKCC algorithm(At the end of the enrollment phase)
- Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery(1 and 4 weeks (early), and 3 and 6 months (late) after surgery)
- Ergonomics of the two different surgical approach(At the end of the enrollment phase)
- Difference in perioperative complications(36 and 72 months)
- Adherence to ESGO surgical Quality Index(36 and 72 months)
- Difference in overall survival and disease-free survival(36 and 72 months)
Investigators
Fanfani Francesco
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
