A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
Start Date
3/22/2022
Completion Date
3/1/2030
Summary
This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.
Detailed Description
This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal hysterectomy with respect to disease free survival. At the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted. Standard arm: Radical or simple hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device). Study arm: Radical or simple hysterectomy is performed as per standard robotic technique (Querleu \& Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
da Vinci
open surgery
Conditions
Locations
Western Regional Medical Center LLC
Goodyear, Arizona 85338
United States
City of Hope
Duarte, California 91010
United States
University of California San Diego Medical Center
Encinitas, California 92024
United States
City of Hope Orange County Lennar Foundation Cancer
Irvine, California 92618
United States
University of California San Diego Medical Center
La Jolla, California 92037
United States
University of California San Diego Moores Cancer Center
La Jolla, California 92093
United States
UCLA Gynecologic Oncology Clinic
Los Angeles, California 90095
United States
Hoag Gynecologic Oncology
Newport Beach, California 92633
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United States
Palo Alto Medical Foundation
Palo Alto, California 94040
United States
Stanford Hospital
Palo Alto, California 94305
United States
University of California San Diego Medical Center
San Diego, California 92103
United States
California Pacific Medical Center-Research Institute
San Francisco, California 91409
United States
City of Hope - Upland
Upland, California 91786
United States
University of California San Diego Medical Center
Vista, California 92081
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Hartford Healthcare Cancer Institute at Hartford Hospital
Hartford, Connecticut 06106
United States
Hartford Healthcare Medical Group-Manchester
Manchester, Connecticut 06042
United States
Harford HealthCare Cancer Institute at the Hospital of Central Connecticut
New Britain, Connecticut 06053
United States
Ascension Medical Group St. Vincent's Obstetrics and Gynecology
Jacksonville, Florida 32204
United States
Mercy Hospital
Miami, Florida 33133
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida 33140
United States
South Miami Hospital
Miami, Florida 33143
United States
South Miami Hospital
Miami, Florida 33143
United States
Mercy Hospital
Miami, Florida 33173
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida 33176
United States
Orlando Health Cancer Center
Orlando, Florida 32806
United States
Orlando Health Winnie Palmer Hospital for Woman and Babies
Orlando, Florida 32806
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Georgian Cancer Center at Augusta University
Augusta, Georgia 30912
United States
Southeastern Regional Medical Center LLC
Newnan, Georgia 30265
United States
St. Vincent Hospital and Health Care Center Inc
Indianapolis, Indiana 46260
United States
St. Vincent Hospital and Health Care Center, Inc
Indianapolis, Indiana 46260
United States
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
Baptist Health
Lexington, Kentucky 40503
United States
LSU Health New Orleans
New Orleans, Louisiana 70112
United States
Willis-Knighton Physician Network Gynecologic Oncology Associates
Shreveport, Louisiana 71118
United States
Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology
Scarborough, Maine 04074
United States
Baystate Medical Center
Springfield, Massachusetts 01199
United States
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota 55455
United States
M Health Fairview University of Minnesota Medical Center-East Bank Hospital
Minneapolis, Minnesota 55455
United States
David C. Pratt Center
St Louis, Missouri 63141
United States
Center of Hope
Reno, Nevada 89511
United States
Memorial Sloan Kettering (Basking Ridge)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering (Bergen)
Montvale, New Jersey 07645
United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico 87131
United States
Northwell Health/South Shore University Hospital
Bay Shore, New York 11706
United States
Northwell Health Physician Partners/Gynecological Oncology at Brightwaters
Brightwaters, New York 11718
United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
Brooklyn, New York 11220
United States
NYU Langone Ambulatory Care Bay Ridge
Brooklyn, New York 11220
United States
NYU Langone Hospital-Brooklym
Brooklyn, New York 11220
United States
Memorial Sloan Kettering (Commack)
Commack, New York 11725
United States
Memorial Sloan Kettering (Westchester)
Harrison, New York 10604
United States
Northwell Health/Huntington Hospital
Huntington, New York 11743
United States
Memorial Sloan Kettering (Monmouth)
Middletown, New York 07748
United States
Northwell Health/Long Island Jewish Medical Center
New Hyde Park, New York 11040
United States
NHPP/Gynecologic Oncology at New Hyde Park
New Hyde Park, New York 11042
United States
Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street
New York, New York 10016
United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York 10016
United States
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York 10029
United States
Josie Robertson Surgery Center
New York, New York 10065
United States
Memorial Sloan Kettering Cancer Center (Main Campus)
New York, New York 10065
United States
Memorial Sloan Kettering (Nassau)
Uniondale, New York 11553
United States
Novant Health Cancer Institute
Charlotte, North Carolina 28204
United States
Duke University Hospital
Durham, North Carolina 27705
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Novant Health Cancer Institute
Greensboro, North Carolina 27403
United States
Novant Health Cancer Institute
Kernersville, North Carolina 27284
United States
Novant Health Cancer Institute
Mount Airy, North Carolina 27030
United States
Novant Health Cancer Institute
North Wilkesboro, North Carolina 28659
United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374
United States
Novant Health Cancer Institute
Statesville, North Carolina 28625
United States
Novant Health Cancer Institute
Thomasville, North Carolina 27360
United States
Novant Health Cancer Institute
Winston-Salem, North Carolina 27103
United States
Summa Health Jean and Milton Copper Pavilion
Akron, Ohio 44304
United States
Summa Health Jean and Milton Copper Pavillion
Akron, Ohio 44304
United States
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio 45220
United States
TriHealth Cancer Institute-Thomas Comprehensive Care Center
Cincinnati, Ohio 45220
United States
University of Cleveland Medical Center
Cleveland, Ohio 44106
United States
OSU Wexner Medical Center Hospital East
Columbus, Ohio 43203
United States
OSU Wexner Medical Center Outpatient Care East
Columbus, Ohio 43203
United States
James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
OSU Wexner Medical Center University Hospital
Columbus, Ohio 43210
United States
OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio 43212
United States
OSU Wexner Medical Center Martha Morehouse Outpatient Care
Columbus, Ohio 43221
United States
OSU Wexner Medical Center Outpatient Care Upper Arlington
Columbus, Ohio 43221
United States
OSU Wexner Medical Center Outpatient Care Gahanna
Columbus, Ohio 43230
United States
OSU Wexner Medical Center Outpatient Care Dublin
Dublin, Ohio 43016
United States
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United States
Kettering Health Cancer Center
Kettering, Ohio 45429
United States
OSU Wexner Medical Center Outpatient Care Lewis Center
Lewis Center, Ohio 43035
United States
OSU Wexner Medical Center Outpatient Care New Albany
Westerville, Ohio 43081
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Legacy Good Samaritan Medical Center-Gynecological Oncology Group
Portland, Oregon 97210
United States
Providence Center Institute Franz Clinic
Portland, Oregon 97213
United States
Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology
Tualatin, Oregon 97062
United States
Abington Memorial Hospital
Abington, Pennsylvania 19001
United States
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Magee - Womens Hospital of UPMC
Pittsburgh, Pennsylvania 15213
United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Asplundh Cancer Pavillion
Willow Grove, Pennsylvania 19090
United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania 19096
United States
Women's and Infants Hospital of Rhode Island Program in Women's Oncology
Providence, Rhode Island 02905
United States
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee 37403
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38119
United States
Texas Oncology-Austin
Austin, Texas 78758
United States
Texas Oncology- GYN ONC DFWW
Bedford, Texas 76022
United States
Texas Oncology-DFWW
Bedford, Texas 76022
United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
United States
University of Texas Southwestern Medical Center-Simmons Cancer Center
Dallas, Texas 75390
United States
University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital
Dallas, Texas 75390
United States
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
Dallas, Texas 75390
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Texas Oncology-GYN ONC DFWW
Fort Worth, Texas 76104
United States
Texas Oncology
Fort Worth, Texas 76104
United States
Texas Oncology-San Antonio
San Antonio, Texas 78240
United States
Texas Oncology-The Woodlands, Gynecologic Oncology
The Woodlands, Texas 77380
United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia 22903
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Inova Health System
Fairfax, Virginia 22031
United States
VCU Health at GreenGate
Henrico, Virginia 23233
United States
VCU Health Emergency Center at New Kent
Quinton, Virginia 23141
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23219
United States
VCU Health Short Pump Pavillion
Richmond, Virginia 23233
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
Virginia Commonwealth University-Main Hospital
Richmond, Virginia 23298
United States
VCU Health at Tappahannock Hospital
Tappahannock, Virginia 25560
United States
VCU Health-William and Mary
Williamsburg, Virginia 23185
United States
Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology
Vancouver, Washington 98686
United States
West Virginia University
Morgantown, West Virginia 26506
United States
West Virginia
Morgantown, West Virginia 26506
United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United States
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
Brazil
Hospital Municipal Vila Santa Catarina
São Paulo, Sao Paula 04378-500
Brazil
Barretos Cancer Hospital
Barretos, São Paulo 14784-400
Brazil
Hospital de Base - Fundacao Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo 15090-000
Brazil
A.C.Camargo Cancer Center
São Paulo, São Paulo 01509001
Brazil
Brazilian National Cancer Institute
Rio de Janeiro, 20081-250
Brazil
Princess Margaret Cancer Center
Toronto, Ontario M5G2M9
Canada
McGill University Health Centre-Glen Site
Montreal, Quebec H4A 3J1
Canada
Centre Hospitalier De L'Universite De Montreal
Montreal, H2X 3E4
Canada
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do 13496
South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Gangnam Severance Hospital
Seoul, Republic of Korea 06273
South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, Republic of Korea 07722
South Korea
Korea University Guro Hospital
Seoul, Republic of Korea 08308
South Korea
Korea University Anam Hospital
Seoul, 02843
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Seoul St. Mary's Hospital - Catholic University
Seoul, 06591
South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, 07722
South Korea