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Clinical Trials/NCT05974995
NCT05974995RecruitingNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country566 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

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

Experimental

Intervention: Robot-assisted surgery (Procedure)

Laparoscopic surgery

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fanfani Francesco

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Sites (1)

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