ISRCTN06393679已完成未知
APPRO: LAParoscopic Prostatectomy Robot Open - a randomised, open trial of radical prostatectomy with or without lymph node dissection as part of a prospective, non-randomised, open trial comparing robot-assisted laparoscopic and open radical prostatectomy
Sahlgrenska University Hospital (Sweden)0 个研究点目标入组 4,003 人开始时间: 2008年2月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 4,003
研究概览
简要总结
2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21114378 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24025241 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23906418 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27531014 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31068176 results (added 10/05/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32343155 results (added 29/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33743059/ (added 22/03/2021) 2024 Results article in https://doi.org/10.1186/s12885-024-12236-3 (added 12/04/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current information as of 02/09/2009:
- •1. Men with localised prostate cancer, stage T1-T3
- •2. No signs of distant metastases, i.e. stage M0
- •3. Prostate-Specific Antigen (PSA) <=20
- •4. All Gleason gradings
- •5. The patient should in all other aspects be judged suitable for radical prostatectomy
- •6. The patient must accept the potential complications with the operation
- •7. Age <=75 years
- •8. No other cancer in case history
- •Added 03/11/2009:
- •The accrual of patients includes every patient at each participating hospital, who gives informed consent, regardless of the experience of the surgeon. Thus the trial will also include patients operated by a surgeon in training (an experience of less than 100 cases). The total number of patients included will therefore surpass the numbers needed for the primary outcome variable.
- •Initial information at time of registration:
- •1. Men with localised prostate cancer, stage T1-T2
- •2. No signs of distant metastases, i.e. stage M0
- •3. Prostate-Specific Antigen (PSA) <=20
- •4. All Gleason gradings
- •5. The patient should in all other aspects be judged suitable for radical prostatectomy
- •6. The patient must accept the potential complications with the operation
- •7. Age <=75 years
- •8. No other cancer in case history
- •For the randomised substudy on regional lymph node dissection:
- •1. Gleason score >=7
- •2. PSA <15
排除标准
- •Current information as of 02/09/2009:
- •History of earlier/other cancer (does not include basal cell cancer)
- •Initial information at time of registration:
- •1. Body Mass Index (BMI) >35
- •2. History of earlier/other cancer (does not include basal cell cancer)
- •3. Men with prostate cancer stage =T3
- •4. Distant metastases
- •5. PSA >20
- •6. Patient not suitable for laparoscopic operation
- •7. Age >75 years
- •8. Concerning the randomised study of regional lymph node dissection:
- •8.1. Gleason <7 och/eller
- •8.2. PSA =15
研究者
相似试验
已完成
不适用
Robot assisted radical prostatectomyJPRN-UMIN000007293The University of Tokyo10
Unknown
不适用
Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical ProstatectomyProstate CancerNCT03351088Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia226
招募中
3 期
Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological OutcomesCancer - ProstateProstate CancerACTRN12617000296336Sydney Local Health District564
已完成
不适用
Robotic Laparoscopic Radical ProstatectomyProstate CancerNCT00292019Lawson Health Research Institute20
已完成
不适用
rodynamics for prostate surgery trial: randomised evaluation of assessment methodsower urinary tract symptomsUrodynamicsUrological and Genital DiseasesISRCTN56164274Southmead Hospital (UK)820