The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach

Completed

• Conditions: Prostatectomy; Prostate Neoplasm
• Interventions: Procedure: the robot-assisted laparoscopic radical prostatectomy

• Registration Number: NCT06020287
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

The goal of this observational study was to compare the perioperative outcomes, postoperative urinary control rates and positive surgical margin (PSM) rates of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach (AP-RARP) with the Retzius-sparing approach (RS-RARP) and anterior approach (anterior-RARP) in the treatment of prostate cancer. The main question it aims to answer was:

• The early therapeutic efficacy of the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach

Participants has been underwent:

* AP-RARP

* RS-RARP

* anterior-RARP Researchers compared the three groups to see if AP-RARP combines the advantages of anterior and posterior RARP and is a feasible surgical option for the treatment of prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-27
• Status Verified: 2023-08
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 233

Inclusion Criteria

• pathologically diagnosed with prostate cancer by prostate biopsy
• underwent robot-assisted laparoscopic surgery
• the surgery performed by Weidong Gan
• the extended pelvic lymphadenectomy (PLA) is performed on patients with high-risk prostate cancer (PSA≥20 ng/ml or Grade Group 4-5 or clinical stage ≥T2c) and those considered to have a possibility of lymph node metastasis based on imaging evaluation.

Exclusion Criteria

• Patients with a clinical and pathological TNM stage ≥T3b and N1
• patients with distant metastasis
• urinary incontinence before surgery
• received neoadjuvant therapy before surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RS-RARP	the robot-assisted laparoscopic radical prostatectomy	the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach
AP-RARP	the robot-assisted laparoscopic radical prostatectomy	the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach
anterior-RARP	the robot-assisted laparoscopic radical prostatectomy	he robot-assisted laparoscopic radical prostatectomy with anterior approach

Primary Outcome Measures

Name	Time	Method
positive surgical margin	2 weeks after surgery	observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist
urinary continence	0-6 month after surgery	was defined as using 0-1 pad a day

Secondary Outcome Measures

Name	Time	Method
intraoperative blood loss	the day of the surgery	Intraoperative bleeding was defined as the sum of blood content in blood gauze, blood content in negative pressure suction bottle and blood clot volume.
operating time	the day of the surgery	The start time of the operation refers to the time of incision of the skin at the surgical site. The end time of surgery refers to the time when the skin is sutured.

Trial Locations

Locations (1)

Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China