NCT04999696

Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer

Minimally Invasive Therapy Versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 820 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. And minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.

Detailed description

Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. Laparotomy has been the surgical method of choice for a considerable length of time. While it is an accepted effective treatment, laparotomy is highly invasive and is associated with increased risk of tissue trauma, intraoperative and postoperative complications, and longer hospital stay. Minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. Retrospective studies have shown that oncologic outcomes in terms of recurrence rates and patterns of recurrence are similar in patients who had a laparoscopic or an open approach to radical hysterectomy. There is reduction of overall postoperative complications, treatment-related morbidity and length of hospital stay. However, there are two studies stating poorer survival of women treated by minimally invasive surgery. An epidemiologic study using two large US databases (National Cancer Database and Surveillance, Epidemiology, and End Results database) showed a reduction in overall survival of patients undergoing minimally invasive radical hysterectomy. Furthermore, in a prospective, multi-center, open-label randomized clinical trial, minimally invasive radical hysterectomy (both total laparoscopic and total robotic radical hysterectomy) was associated with significantly worse disease-free survival and overall survival compared to open abdominal radical hysterectomy among women with early stage cervical cancer. Recurrence rates were also higher in the minimally invasive group. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.

Conditions

• Cancer of Cervix
• Laparoscopic Surgery

Interventions

Type	Name	Description
PROCEDURE	radical hysterectomy	To compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy

Timeline

• Start date: 2023-09-01
• Primary completion: 2031-07-01
• Completion: 2033-07-01
• First posted: 2021-08-11
• Last updated: 2023-02-10

Locations

1 site across 1 country: Taiwan