Document Detail


A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer.
MedLine Citation:
PMID:  18722970     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
STUDY 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.
DESIGN: 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).
SETTING: Tertiary referral hospital.
PATIENTS: Patients with histologically confirmed invasive squamous cell carcinoma or adenocarcinoma of the cervix, stage IA1 (with lymphovascular space invasion), IA2, and IB1 are eligible.
INTERVENTIONS: 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.
MEASUREMENTS AND MAIN 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.
CONCLUSION: 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:
Andreas Obermair; Val Gebski; Michael Frumovitz; Pamela T Soliman; Kathleen M Schmeler; Charles Levenback; Pedro T Ramirez
Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of minimally invasive gynecology     Volume:  15     ISSN:  1553-4650     ISO Abbreviation:  J Minim Invasive Gynecol     Publication Date:    2008 Sep-Oct
Date Detail:
Created Date:  2008-08-25     Completed Date:  2009-01-27     Revised Date:  2014-11-14    
Medline Journal Info:
Nlm Unique ID:  101235322     Medline TA:  J Minim Invasive Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  584-8     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adenocarcinoma / pathology,  surgery*
Adult
Carcinoma, Squamous Cell / pathology,  surgery*
Cost-Benefit Analysis
Disease-Free Survival
Feasibility Studies
Female
Humans
Hysterectomy / methods*
Laparoscopy / methods*
Neoplasm Staging
Robotics*
Uterine Cervical Neoplasms / pathology,  surgery*
Grant Support
ID/Acronym/Agency:
T32 CA101642/CA/NCI NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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