Comparison of the Integrated Posterior-Anterior-Lateral Approach and the Posterior Approach in Robotic Radical Prostatectomy

Zhengzhou University

Status: Completed

Conditions: Robot Assisted Laparoscopic Radical Prostatectomy; Prostate; Urologic Cancer

Treatments: Procedure: PAL combined approach group; Procedure: posterior approach group

Study type: Interventional

Funder types: Other

Identifiers

NCT07305142

2024-KY-0820-002

Details and patient eligibility

About

This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was:

What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.

Enrollment: 60 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate biopsy confirms prostate cancer;
• Clinical T stage <=T3a stage;
• Fully understand clinical trial protocols and sign informed consent;

Exclusion criteria

• Urinary incontinence before surgery;
• Previous endoscopic prostate surgery;
• There are serious underlying diseases that cannot tolerate surgery or have a survival of less than 5 years;
• Metastatic disease is present or lymph node involvement is suspected at diagnosis;
• Patients judged by the investigator to be unsuitable for participation in this clinical trial;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PAL-RAPA

Active Comparator group

Description:

Participants undergo robot-assisted laparoscopic radical prostatectomy(RAPA) via an integrated Posterior-Anterior-Lateral (PAL) approach using the da Vinci system. * Posterior:\*\* mobilize sigmoid colon, incise rectovesical peritoneum, dissect vas deferens and seminal vesicles, open Denonvilliers' fascia, create a fascial window at prostate base. * Anterior:\*\* enter retropubic space, preserve endopelvic fascia, puboprostatic ligaments, dorsal venous complex, expose bladder neck and anterior prostate. * Lateral:\*\* dissect lateral bladder neck/prostate base, expand triangular space, retract seminal vesicle through posterior window, incise bladder neck, control vascular pedicles, perform atraumatic neurovascular bundle dissection, preserve urethral length. * Prostate removal\*\* is followed by \*\*continuous urethrovesical anastomosis\*\* with 3-0 barbed suture. \*\*Intended Purpose of Intervention:\*\* Assess perioperative outcomes, early functional recovery, and oncologic safety of PAL-RAPA

Treatment:

Procedure: PAL combined approach group

Posterior RAPA

Active Comparator group

Description:

Participants undergo robot-assisted laparoscopic radical prostatectomy via a posterior-only approach using the da Vinci system. The procedure includes: mobilization of the sigmoid colon, incision of the rectovesical peritoneum, dissection of vas deferens and seminal vesicles, opening of Denonvilliers' fascia, and creation of a fascial window at the prostate base. Prostate removal is followed by continuous urethrovesical anastomosis using a 3-0 barbed suture.

Treatment:

Procedure: posterior approach group