Prostatectomy Clinical Trials

Clinical trials related to Prostatectomy Procedure

Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Men aged 18 years ≤ age ≤ 75 years;

• Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.

• Gleason Score\<8.

• PSA\<20ng/ml.

• Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;

• The patient has healthy sexual function before surgery and intention for sexual activities after surgery;

• Physiological condition acceptable for laparoscopic surgery;

• Willing to cooperate and complete the study follow-up and related examinations;

• The subject or his agent voluntarily participates in this trial and signs the written informed consent;

⁃ The questionnaire can be completed in Chinese.

⁃ The patient has been informed of the trial;

Locations
Other Locations
China
Changzheng hospital
RECRUITING
Shanghai
Contact Information
Primary
Shancheng Ren, MD/PhD
renshancheng@gmail.com
139 1779 3885
Backup
Yi fan Chang
13661652533@163.com
13661652533
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 480
Treatments
Experimental: Single-port extraperitoneal RARP
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques
Active_comparator: Multi-port transperitoneal RARP
Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques
Related Therapeutic Areas
Sponsors
Collaborators: ShuGuang Hospital, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, Sir Run Run Shaw Hospital
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov