Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
Recruiting
Phase 4
Interventional Study
Prostate Carcinoma
Prostate Neoplasm
Pain Intensity Assessment
Quality of Life (QOL)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Male
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 200 (estimated)
- Sponsor
- Brazilian Institute of Robotic Surgery · Other
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About This Trial
The AirSeal platform has been evaluated in urological surgeries, mainly in cases of malignant diseases 5,6. However, there is still a lack of data demonstrating the possible benefits of its use, which justifies the conduct of this research in order to aggregate such knowledge. Therefore, the objective of this prospective pilot study is to compare and evaluate the role of low-pressure pneumoperiton…
Trial Locations
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Eligibility 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, metastasi…
Contacts