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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAL-RAPA | Active Comparator | Participants undergo robot-assisted laparoscopic radical prostatectomy(RAPA) via an integrated Posterior-Anterior-Lateral (PAL) approach using the da Vinci system.
**Intended Purpose of Intervention:** Assess perioperative outcomes, early functional recovery, and oncologic safety of PAL-RAPA |
|
| Posterior RAPA | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAL combined approach group | Procedure | PAL combined approach was performed to resect the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| urinary continence | was defined as the use of zero to one safety pad per day without any involuntary leakage.Immediate continence was defined as continence within seven days after catheter removal, while early continence was defined as continence achieved within three months. | Patients were assessed for urinary incontinence, defined according to established criteria, via telephone at five time points after the removal of the urinary catheter (which was 2-3 weeks post-surgery): within 7 days, and at 1, 3, 6, and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | During operation | |
| Estimated blood loss | During operation | |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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One year after the completion of the research
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2024 | Dec 2, 2025 |
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| posterior approach group | Procedure | Intraoperative resection of the prostate was performed by posterior approach |
|
Complications were classified according to the Clavien-Dindo system, and those of grade II or higher were documented in this study.
| Perioperative |
| Time for removal of drainage tube | Perioperative |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2024 | Dec 2, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
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