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Completed

NCT Number: NCT06020287

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

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.

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Key information

Conditions

Prostatectomy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Neoplasm Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the robot-assisted laparoscopic radical prostatectomy

Procedure

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2023
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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