Clinical trial · Interventional
Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy
Retzius-sparing Versus Retzius-repairing Robotic-assisted Radical Prostatectomy: A Prospective Randomized Comparison on Functional Outcomes With a 1-year Follow-up
NCT05224024CI-TRIAL-00056320unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP. This study is a single-centre, single-surgeon and a prospective randomized study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Urinary Incontinence,Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Retzius-repairing robot-assisted radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Retzius-repairing robot-assisted radical prostatectomy group
- description
- This group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy.
- interventionNames
- Procedure: Retzius-repairing robot-assisted radical prostatectomy
- type
- PLACEBO_COMPARATOR
- label
- Retzius-sparing robot-assisted radical prostatectomy group
- description
- This group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy.
- interventionNames
- Procedure: Retzius-repairing robot-assisted radical prostatectomy
Primary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patients, * Life expectancy \> 10 years, * Clinically organ confined disease (cT1-cT2), * Biopsy Gleason score ≤ 7, * Total serum PSA ≤ 10 ng/ml, * Normal preoperative continence and potency. Exclusion Criteria: * Pre-existing urinary incontinence, * Any previous prostatic, urethral, bladder neck surgery, * Neoadjuvant therapy.
References
Publications (4)
- RESULTGalfano A, Ascione A, Grimaldi S, Petralia G, Strada E, Bocciardi AM. A new anatomic approach for robot-assisted laparoscopic prostatectomy: a feasibility study for completely intrafascial surgery. Eur Urol. 2010 Sep;58(3):457-61. doi: 10.1016/j.eururo.2010.06.008. Epub 2010 Jun 16. PMID 20566236
- RESULTGalfano A, Di Trapani D, Sozzi F, Strada E, Petralia G, Bramerio M, Ascione A, Gambacorta M, Bocciardi AM. Beyond the learning curve of the Retzius-sparing approach for robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of the first 200 patients with >/= 1 year of follow-up. Eur Urol. 2013 Dec;64(6):974-80. doi: 10.1016/j.eururo.2013.06.046. Epub 2013 Jul 8. PMID 23856036
- RESULTGalfano A, Panarello D, Secco S, Di Trapani D, Barbieri M, Napoli G, Strada E, Petralia G, Bocciardi AM. Does prostate volume have an impact on the functional and oncological results of Retzius-sparing robot-assisted radical prostatectomy? Minerva Urol Nefrol. 2018 Aug;70(4):408-413. doi: 10.23736/S0393-2249.18.03069-2. Epub 2018 Mar 28. PMID 29595042
- RESULTvan der Poel HG, de Blok W, Joshi N, van Muilekom E. Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy. Eur Urol. 2009 Apr;55(4):892-900. doi: 10.1016/j.eururo.2009.01.021. Epub 2009 Jan 21. PMID 19171418