An innovative approach for robotic-assisted laparoscopic radical prostatectomy: a single-hospital study
| ISRCTN | ISRCTN10803536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10803536 |
- Submission date
- 11/08/2023
- Registration date
- 30/08/2023
- Last edited
- 23/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Robot-assisted laparoscopic radical prostatectomy (RARP) is a surgical treatment for prostate cancer patients without metastasis (when the cancer hasn't spread). Injury of the nerve near the prostate during the operation could lead to incontinence or erectile disability. The pubovesical complex-sparing RARP technique can preserve essential nerves for urine and sexual function better. This study aimed to describe the steps of the pubovesical complex-sparing laparoscopic RARP technique and report the functional and oncological outcomes.
Who can participate?
Clinically localized prostate cancer patients aged between 18 and 70 years
What does the study involve?
All patients received pubovesical complex-sparing laparoscopic RARP. Personal data including urine and sexual function is recorded before the operation. The surgical outcome was recorded after the operation. The treatment course was the same as other prostate cancer patients. The only difference was the surgical method.
What are the possible benefits and risks of participating?
A benefit is that the outcome of pubovesical complex-sparing laparoscopic RARP is expected to achieve an international level. There are no major complications.
Where is the study run from?
Tungs' Taichung MetroHarbor Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
January 2019 to December 2022
Who is funding the study?
Tungs' Taichung MetroHarbor Hospital (Taiwan)
Who is the main contact?
Chin-Heng, Lu, chinhenglu@gmail.com (Taiwan)
Contact information
Public
Tung's Taichung Metroharbor Hospital
No.699, Sec. 8, Taiwan Blvd.
Taichung City
435
Taiwan
 ORCID ID |
0000-0003-3707-6423 |
|---|---|
| Phone | +886 (0)980985308 |
| chinhenglu@gmail.com |
Study information
| Study design | Single-institution case series observational report for 2 years |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pubovesical Complex-sparing Technique during Robotic-assisted Laparoscopic Radical Prostatectomy functional and oncologic outcomes report: a single-institution case series |
| Study acronym | Modified PCS RARP |
| Study objectives | This study aimed to describe the steps of the PVC-sparing technique and report functional and oncological outcomes. |
| Ethics approval(s) |
Approved 15/04/2020, Institutional Review Board of Tungs’ Taichung Metroharbor Hospital (No.699, Section 8, Taiwan Boulevard, Wuqi District, Taichung City, 43503, Taiwan; +886-4-26581919#4635; d3905@ms3.sltung.com.tw), ref: 109007 |
| Health condition(s) or problem(s) studied | Surgical skill introduction and surgical outcome report for clinically localized prostate cancer patients with specific surgical treatment |
| Intervention | Surgical skill introduction and surgical outcome report for patients who received pubovesical complex-sparing robotic-assisted laparoscopic radical prostatectomy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Erectile function measured using the International Index of Erectile Function (IIEF)-5 score preoperatively and at follow-up for at least 2 years |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2019 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target number of participants | 35 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. Male patients aged over 18 years and <70 years 2. Clinically organ-confined disease (cT1–cT2) staged by CT scan 3. Gleason score ≤7 4. Total PSA ≤10 ng/mL. PSA or biochemical failure was defined as two serial serum PSA results >0.2 ng/mL 5. Prostate volume <60 mL 6. Normal preoperative continence and sexual function. Patients had to be completely continent (pad-free) and have an IIEF score ≥17 at baseline. Continence was defined as not using pads. Potency was defined as achieving full erection during sexual intercourse with or without using phosphodiesterase 5 inhibitors (PDE5-Is). |
| Key exclusion criteria | 1. Neoadjuvant hormonal therapy 2. Previous prostate, urethra, or bladder neck surgery 3. Bilateral NVBs were not preserved 4. Salvage RALP 5. Anteriorly located tumours |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 30/09/2020 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taichung City
43503
Taiwan
Sponsor information
Hospital/treatment centre
No.699, Sec. 8, Taiwan Blvd
Taichung City
435
Taiwan
| Phone | +886 (0)4-26581919#4960 |
|---|---|
| ycou228@gmail.com | |
| Website | https://en.sltung.com.tw/ |
"ROR" |
https://ror.org/0452q7b74 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical and legal restrictions. |
Editorial Notes
23/08/2023: Study's existence confirmed by the Institutional Review Board of Tungs’ Taichung Metroharbor Hospital.
