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

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06020287
• Other study ID #: NanjingUSM202388
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: December 27, 2022

Study information

• Verified date: August 2023
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 27, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatectomy
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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