Comparison between laparoscopic (keyhole surgery) and robot-assisted surgery for patients with prostate cancer
| ISRCTN | ISRCTN11552140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11552140 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 136/2009 |
| Sponsor | University of Turin |
| Funder | Investigator initiated and funded |
- Submission date
- 03/04/2022
- Registration date
- 10/06/2022
- Last edited
- 04/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Radical prostatectomy (RP; a surgical procedure that removes the prostate gland and attached seminal vesicles) is a common treatment for patients with clinically localised prostate cancer (PCa) and a life expectancy greater than 10 years. Surgery is traditionally performed by open retropubic RP, although laparoscopic (keyhole) RP (LRP) and especially robot-assisted RP (RARP) have become popular in the last 15 years. Although the advantages of laparoscopy over open surgery, at least in terms of minimal invasiveness, are well known, LRP and RARP have rarely been compared. The primary objective of the study is to compare the safety and efficacy of the laparoscopic and robot-assisted techniques in radical prostatectomy surgery by analysing peri-operative and follow-up data from patients operated using these techniques at San Luigi Gonzaga Hospital (Orbassano, Italy).
Who can participate?
Men between 50 and 75 years of age with localised or locally advanced prostate cancer
What does the study involve?
Participants who meet the inclusion criteria and are willing to undergo surgery are asked to join this study. Participants are randomly allocated to one of two groups:
- group A: will undergo LRP
- group B: will undergo RALP
Patients are followed up for 10 years
What are the possible benefits and risks of participating?
Recently, several studies have been published on the use of RARP, which have confirmed results comparable to LRP in terms of mini-invasiveness and encouraging results in terms of functional outcomes. Literature suggests RARP decreases bleeding, shortens the length of hospital stay, and decreases the readmission and total perioperative complication rates compared with other approaches without impairing the oncologic outcome. For these reasons, patients randomized to the two groups may differ in intra- and postoperative complications, recovery of urinary continence and erectile function, and oncological outcome depending on the surgical technique they underwent.
Where is the study run from?
The study is being run from San Luigi Gonzaga Hospital, Orbassano (Turin), Italy
When is the study starting and how long is it expected to run for?
Octover 2009 to January 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Francesco Porpiglia
porpiglia@libero.it
Contact information
Principal investigator
Regione Gonzole 10
Orbassano (Turin)
10043
Italy
 ORCID ID |
0000-0002-0752-4857 |
|---|---|
| Phone | +30 0119026485 |
| porpiglia@libero.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of laparoscopic and robot-assisted radical prostatectomy for patients with localized prostate cancer: analysis of benefits and complications in a prospective randomised study |
| Study objectives | The aim of the study is to compare the safety and efficacy of the laparoscopic and robot-assisted techniques in radical prostatectomy surgery by analysing peri-operative and follow-up data from patients operated. |
| Ethics approval(s) | Approved 01/10/2009, San Luigi Gonzaga Hospital Ethics committee (Regione Gonzole 10, Orbassano, Turin, Italy; +39 0119026204; sperimentazioni@sanluigi.piemonte.it), ref: N 136/2009 |
| Health condition(s) or problem(s) studied | Surgical treatment of localized prostate cancer |
| Intervention | All patients who are candidates for radical prostatectomy will be randomised into two groups: - Group A: will undergo laparoscopic radical prostatectomy (LRP); - Group B: will undergo robot-assisted radical prostatectomy (RALP). A two-armed randomisation scheme will be generated by means of a specific "query" to the website www.randomization.com. A typical video laparoscopic radical prostatectomy with a transperitoneal approach will be performed. When necessary extended pelvic lymphadenectomy will be associated. Both groups will be treated with the same anaesthesia protocol both intraoperatively (general anaesthesia) and immediately after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Postoperative urinary continence will be assessed with ICS questionnaire at 1, 3, 6, 12, 60 and 120 months after surgery. |
| Key secondary outcome measure(s) |
1. Serum PSA levels will be assessed at 1, 3, 6, 12, 60 and 120 months after surgery |
| Completion date | 01/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 100 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Aged between 50 and 75 years 2. Diagnosed with localised or locally advanced prostate adenocarcinoma (clinical stage T1-2 or T3, in each case N0, M0) 3. Gleason score between 2 and 10 4. PSA <20ng/ml |
| Key exclusion criteria | Patients who withdraw consent |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
Orbassano (Turin)
10043
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to authors’ elect. The data will be held by the corresponding author. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/07/2012 | 21/04/2022 | Yes | No | |
| Results article | Ten-year follow up | 04/04/2024 | 04/04/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/04/2024: Publication reference added.
21/04/2022: Trial's existence confirmed by San Luigi Gonzaga Hospital Ethics committee.
