Prostate, Robot Assisted Laparoscopic Radical Prostatectomy, Urologic Cancer
Conditions
Brief summary
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.
Interventions
PROCEDUREPAL combined approach group
PAL combined approach was performed to resect the prostate
PROCEDUREposterior approach group
Intraoperative resection of the prostate was performed by posterior approach
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary continence | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | During operation | — |
| Estimated blood loss | During operation | — |
| Complications | Perioperative | Complications were classified according to the Clavien-Dindo system, and those of grade II or higher were documented in this study. |
| Time for removal of drainage tube | Perioperative | — |
Countries
China
Outcome results
None listed