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

What this Trial Is About

Researchers are evaluating the best minimally invasive surgical method for women with morbid obesity (BMI 30) who have early-stage endometrial cancer. This study is a randomized controlled trial comparing robotic-assisted surgery and conventional laparoscopic surgery to determine which approach is more suitable in these patients. The aim is to confirm previous observations suggesting benefits of robotic surgery and to gather robust data in this specific patient group. The study involves two groups: one receiving robotic-assisted surgery using the DaVinci Xi system, and the other undergoing standard laparoscopic surgery. Both procedures include total hysterectomy with bilateral salpingo-oophorectomy and lymph node staging, with attention to sentinel lymph node mapping. The trial will also assess adherence to surgical algorithms, perioperative complications, surgical duration, ergonomics, quality of life, and long-term survival outcomes. Participants will be monitored throughout the study with evaluations at various time points, including quality of life assessments at baseline, 1, 4 weeks, and 3, 6 months post-surgery. Researchers will measure the primary outcome of conversion rates from minimally invasive surgery to laparotomy. Secondary outcomes include surgical duration, complications, adherence to protocols, ergonomics scores, and survival measures over up to 72 months. This comprehensive follow-up aims to provide data on safety, effectiveness, and patient experience during and after surgery.

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