Comparison of the Integrated Posterior-Anterior-Lateral Approach and the Posterior Approach in Robotic Radical Prostatectomy
NCT ID: NCT07305142
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-05-16
2025-12-02
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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PAL-RAPA
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
PAL combined approach group
PAL combined approach was performed to resect the prostate
Posterior RAPA
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.
posterior approach group
Intraoperative resection of the prostate was performed by posterior approach
Interventions
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PAL combined approach group
PAL combined approach was performed to resect the prostate
posterior approach group
Intraoperative resection of the prostate was performed by posterior approach
Eligibility Criteria
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Inclusion Criteria
* Clinical T stage \<=T3a stage;
* Fully understand clinical trial protocols and sign informed consent;
Exclusion Criteria
* 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;
40 Years
80 Years
MALE
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Xuepei Zhang
Director of Urology
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2024-KY-0820-002
Identifier Type: -
Identifier Source: org_study_id