ClinicalTrials.gg
CompletedNCT06020287Updated Aug 31, 2023

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

An observational study in Prostatectomy and Prostate Neoplasm, sponsored by Nanjing University School of Medicine. Completed at 1 site in China. Open to male participants. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Nanjing University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
233
Sex
Male
01

Study 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.
02

Conditions studied

  • Prostatectomy
  • Prostate Neoplasm

Browse trials for

03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 233 is above the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Nanjing University School of Medicine is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
233 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurethe 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.

06

What researchers measure

Primary outcomes

  1. urinary continence

    was defined as using 0-1 pad a day

    Time frame: 0-6 month after surgery

  2. positive surgical margin

    observed whether the tissue cutting in surgery has tumor cell in surgical margin by pathologist

    Time frame: 2 weeks after surgery

Secondary outcomes

  1. 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.

    Time frame: the day of the surgery

  2. 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.

    Time frame: the day of the surgery

07

Study locations

1 site
  • Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06020287
Lead sponsor
Nanjing University School of Medicine
Responsible party
Fan Feng (Attending Doctor, Nanjing University School of Medicine) — Principal investigator
First posted
Aug 31, 2023
Start date
Sep 1, 2020
Primary completion
May 31, 2022
Completion
Dec 27, 2022
Last update
Aug 31, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion