Clinical trial · Interventional
Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
Pilot Feasibility Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer
NCT04319146CI-TRIAL-00098451AMBUPROactive not recruitingN/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 promoter propose a pilot study evaluating the feasability of robot-assisted radical prostatectomy on outpatient in patients with localized prostate cancer. This study will enrole a total of 20 patients over one center, followed for 1 month. The total study duration will be 15 months, including statistical analysis and publication.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robot-assisted radical prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- robot-assisted radical prostatectomy
- description
- patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis
- interventionNames
- Procedure: robot-assisted radical prostatectomy
Primary outcomes (1)
- measure
- Absence of conventional hospitalization after robot-assisted radical prostatectomy
- timeFrame
- 24 hours following the intervention
Secondary outcomes (7)
- measure
- Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization.
- timeFrame
- 24 hours following the intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men * Older than 18 years old, if\> 70 years old, then patient having had a favorable onco-geriatric consultation (Balducci 2 and life expectancy\> 10 years) * Patient with localized prostate cancer applying for radical prostatectomy treatment * Patient accepting outpatient surgery * Radical prostatectomy performed as first-line treatment * BMI \<35 * ASA score \<3 * Accompanying person available (taxi authorized) to ensure return home * Have quick access to a telephone line * Patient who signed their informed consent * Patient covered by social security or other health insurance Exclusion Criteria: * History of major abdominal surgery * History of pelvic radiotherapy * History of major urogenital malformation * Sleep apnea syndrome * Taking the following drugs within 48 hours (Plavix®, anti-vitamin K / curative LMWH) * Contraindication to ambulatory medical care * Inability to understand and sign the informed consent and to complete the self-questionnaires * Vulnerable people
References
Publications (0)
Data not yet available
No reference posted for this study.