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

NCT06020287 | Completed

• 1 other identifier: NanjingUSM202388
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatectomy; Prostate Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• operating time

  the day of the surgery

• intraoperative blood loss

  the day of the surgery

Study Arms (3)

AP-RARP

the robot-assisted laparoscopic radical prostatectomy combined anterior and posterior approach

Procedure: the robot-assisted laparoscopic radical prostatectomy

RS-RARP

the robot-assisted laparoscopic radical prostatectomy with the Retzius-sparing approach

Procedure: the robot-assisted laparoscopic radical prostatectomy

anterior-RARP

he robot-assisted laparoscopic radical prostatectomy with anterior approach

Procedure: the robot-assisted laparoscopic radical prostatectomy

Interventions

the robot-assisted laparoscopic radical prostatectomy PROCEDURE

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.

AP-RARP; RS-RARP; anterior-RARP

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: December 27, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)