title: A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer.
abstract: OBJECTIVE
  Cervical cancer is a significant health problem in countries of the developing world. Although case series suggest advantages of total laparoscopic radical hysterectomy (TLRH) compared with total abdominal radical hysterectomy (TARH), no randomized controlled trial is currently available to establish TLRH as the new standard treatment. In this study, TLRH or total robotic radical hysterectomy (TRRH) will be performed without a vaginally assisted portion of the procedure.
  
  
  METHODS
  A biphasic randomized controlled trial was designed to test feasibility of recruitment and equivalence in regard to disease-free survival (Canadian Task Force classification I).
  
  
  METHODS
  Tertiary referral hospital.
  
  
  METHODS
  Patients with histologically confirmed invasive squamous cell carcinoma or adenocarcinoma of the cervix, stage IA1 (with lymphovascular space invasion), IA2, and IB1 are eligible.
  
  
  METHODS
  During the first phase, 100 patients will be randomized (1:1) to receive either TLRH/TRRH or TARH, with the primary end point being the rate of enrollment. During the second phase, recruitment will be extended by another 640 patients in a 1:1 TLRH/TRRH:TARH allocation, to determine equivalence with respect to disease-free survival with 80% power and alpha=0.05.
  
  
  RESULTS
  Equivalence will be assumed if the difference in disease-free survival does not exceed 7% at 4 years. Secondary outcomes include treatment-related morbidity, costs and cost effectiveness, patterns of recurrence, quality of life, pelvic floor function, feasibility of intraoperative sentinel node sampling, and overall survival. All data from this multicenter study will be entered using online electronic case report forms, allowing real-time assessment of data completeness and patient follow-up.
  
  
  CONCLUSIONS
  This prospective trial aims to show the equivalence of a TLRH/TRRH versus TARH approach for patients with early stage cervical cancer following a 2-phase protocol. This trial was developed and designed with the input and approval of the members of the Gynecologic Oncology Committee from the American Association of Gynecologic Laparoscopists.
authors: University of Queensland, School of Medicine, Department of Gynecological Oncology, Royal Brisbane and Women's Hospital, Herston, Brisbane, Queensland, Australia. Andreas_obermair@health.qld.gov.au
authors: Andreas
authors: A
authors: Obermair
authors: Val
authors: V
authors: Gebski
authors: Michael
authors: M
authors: Frumovitz
authors: Pamela T
authors: PT
authors: Soliman
authors: Kathleen M
authors: KM
authors: Schmeler
authors: Charles
authors: C
authors: Levenback
authors: Pedro T
authors: PT
authors: Ramirez
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D000328:Adult; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D010535:Laparoscopy / Q000379:methods*; D009367:Neoplasm Staging; D012371:Robotics; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000601:surgery*