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

The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Neoplasm; Prostatectomy
• Intervention / Treatment: Procedure: the robot-assisted laparoscopic radical prostatectomy

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The clinical data of 233 patients treated between September 2020 and May 2022 at Nanjing Drum Tower Hospital were retrospectively analyzed.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AP-RARP; the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach	Procedure: the robot-assisted laparoscopic radical prostatectomy; We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.
RS-RARP; the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach	Procedure: the robot-assisted laparoscopic radical prostatectomy; We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.
anterior-RARP; he robot-assisted laparoscopic radical prostatectomy with anterior approach	Procedure: the robot-assisted laparoscopic radical prostatectomy; We collect medical data of 233 patients with clinically localized prostate cancer who underwent AP-RARP, RS-RARP or anterior-RARP. Perioperative outcomes, including operation time, intraoperative blood loss, intraoperative and postoperative transfusion, postoperative infection, and anastomotic leakage, were compared among the three groups. The postoperative continence rates and PSM rates were also compared.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	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.	the day of the surgery
intraoperative blood loss	Intraoperative bleeding was defined as the sum of blood content in blood gauze, blood content in negative pressure suction bottle and blood clot volume.	the day of the surgery

Collaborators and Investigators

• Sponsor: Nanjing University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NanjingUSM202388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No