Using the AirSeal System for Robot-assisted Prostate Surgery
Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
This study tests if using the AirSeal system during robot-assisted prostate surgery can lead to better results, like shorter hospital stays and fewer complications, for men with prostate cancer compared to traditional methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | Brazilian Institute of Robotic Surgery Academic / other |
| Locations | 2 sites (Salvador, Estado de Bahia and 1 other locations) |
| Trial ID | NCT06784986 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the AirSeal system in providing low-pressure pneumoperitoneum during robot-assisted radical prostatectomy for patients with prostate cancer. The study compares outcomes between patients using the AirSeal system and those using conventional insufflation methods. It aims to gather data on operative times, hospital stays, and complication rates associated with the AirSeal system. The research seeks to establish the cost-benefit and overall effectiveness of this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with prostate cancer who are scheduled for robotic prostatectomy.
Not a fit: Patients over 65 years old, under 18 years old, or those with chronic renal failure or other existing neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for prostate cancer patients undergoing robotic surgery.
How similar studies have performed: Preliminary studies have shown promise for the AirSeal system in urological surgeries, suggesting potential benefits, though this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with prostate cancer who will undergo robotic prostatectomy; Exclusion Criteria: * Patients over 65 and under 18 years of age; * Patients allergic to NSAIDs and/or Morphine and/or Tramadol; * Patients with chronic renal failure; * Patients with recurrence, metastasis and other existing neoplasms.
Where this trial is running
Salvador, Estado de Bahia and 1 other locations
- Instituto Brasileiro de Cirurgia Robotica — Salvador, Estado de Bahia, Brazil (Recruiting)
- Hospital Mater Dei Salvador — Salvador, Estado de Bahia, Brazil (Recruiting)
Study contacts
- Principal investigator: Nilo J. Md — Brazilian Institute of Robotic Surgery
- Study coordinator: Nilo Jorge Leão Coordenador
- Email: ibcrpesquisa@gmail.com
- Phone: +55 71 2626-3030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.