Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
1 other identifier
interventional
80
1 country
1
Brief Summary
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 14, 2020
July 1, 2020
2 years
May 13, 2019
July 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (21)
The console time
The time which surgeon spends on the robot console by minuite
During the surgery
Mean of blood loss
Milliliter
During the surgery
Perioperative transfusion rate (%)
The number of cases which will be transfused.
Up to 1 month after operation
The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Number of cases, based on the result of pathology.
Up to 1 week after operation
Number of blood units transfused
Milliliter
Up to 1 week after operation
the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Percentage
Up to 1 weeks after the surgery.
The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain. The mean score will be calculated to reflect the post-operative pain.
Up to 3 month after surgery
Change of hemoglobin from baseline
(mg/mL)
Up to 1 week after operation
The drainage time
(day),
Up to 3 months after surgery
To assess urethral catheter time, urethral catheter time
(day)
Up to 3 months after surgery
To assess bowel movement recovery time,
(day)
Up to 1 week after surgery
To assess postoperative hospital stay
(day)
Up to 1 month after surgery
The rate of postoperative complications (including infections)
Percentage
in day 3, day 7, and 1 month after surgery.
PSA level in blood
(mg/mL)
Before operation
PSA level in blood
(mg/mL)
6 weeks post-operation
PSA level in blood
(mg/mL)
3 months post-operation
PSA level in blood
(mg/mL)
6 months post-operation
PSA level in blood
(mg/mL)
12 months post-operation
local and regional recurrences on sonography
including ultrasound when PSA rising or any indication of recurrent
through study completion, an average of 1 year
local and regional recurrences, on MRI
including MRI when PSA rising or any indication of recurrent
through study completion, an average of 1 year
local and regional recurrences, on PET Scan
including PET Scan, when PSA rising or any indication of recurrent
through study completion, an average of 1 year
Secondary Outcomes (12)
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Preoperative
Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
3 months postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
6 months, postoperative
Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
12 months postoperative.
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Preoperative
- +7 more secondary outcomes
Study Arms (2)
Robotic-assisted surgery
ACTIVE COMPARATORLaparoscopic surgery
SHAM COMPARATORInterventions
The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
Eligibility Criteria
You may qualify if:
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
You may not qualify if:
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Binh Dan Hospital
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hung V Tran, MD, PhD
Binh Dan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
July 9, 2019
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share