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

August 27, 2023 updated by: Fan Feng, Nanjing University School of Medicine

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 0-6 month after surgery
was defined as using 0-1 pad a day
0-6 month after surgery
positive surgical margin
Time Frame: 2 weeks after surgery
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
Time Frame: 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.
the day of the surgery
intraoperative blood loss
Time Frame: 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.
the day of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Neoplasm

Clinical Trials on the robot-assisted laparoscopic radical prostatectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe