The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06020287
Recruitment Status : Completed
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Fan Feng, Nanjing University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Prostatectomy Prostate Neoplasm Procedure: the robot-assisted laparoscopic radical prostatectomy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Early Therapeutic Efficacy of The Robot-Assisted Laparoscopic Radical Prostatectomy Combined Anterior and Posterior Approach: A Single-Center Retrospective Cohort Study
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : December 27, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. urinary continence [ Time Frame: 0-6 month after surgery ]
    was defined as using 0-1 pad a day

  2. positive surgical margin [ Time Frame: 2 weeks after surgery ]
    observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020287


Locations
Layout table for location information
China, Jiangsu
Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
Nanjing University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fan Feng, Attending Doctor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT06020287    
Other Study ID Numbers: NanjingUSM202388
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases