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

Sponsor
Nanjing University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT06020287
Collaborator
(none)
233
1
27.8
8.4

Study Details

Study Description

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 Phase
  • Procedure: the robot-assisted laparoscopic radical prostatectomy

Study Design

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 :
Sep 1, 2020
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Dec 27, 2022

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. urinary continence [0-6 month after surgery]

    was defined as using 0-1 pad a day

  2. positive surgical margin [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 [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 [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fan Feng, Attending Doctor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT06020287
Other Study ID Numbers:
  • NanjingUSM202388
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2023