Clinical trial · Interventional
Ultralow Versus Standard Pneumoperitoneum Pressure
Randomized Study of Ultralow Versus Standard Pneumoperitoneum Pressure During Robotic Prostatectomy Using the AirSeal® Insufflation System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution
Summary
Brief summary (as posted)
The investigators plan to compare insufflation pressures during robotic assisted laparoscopic prostatectomy (RALP). Standard pressure is typically 15 mmHg, while in a previous study the investigators determined that 6 mmHg is possible routinely. Therefore, the investigators plan to compare the clinical outcomes of participants at a pneumoperitoneal pressure of 15 versus 6 mmHg.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneumoperitoneum Pressure 15 mmHg | Other | — | UNRESOLVED |
| Pneumoperitoneum Pressure 6 mmHg | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pressure 6 mmHg
- description
- Pneumoperitoneum Pressure 6 mmHg
- interventionNames
- Other: Pneumoperitoneum Pressure 6 mmHg
- type
- ACTIVE_COMPARATOR
- label
- Pressure 15 mmHg
- description
- Pneumoperitoneum Pressure 15 mmHg
- interventionNames
- Other: Pneumoperitoneum Pressure 15 mmHg
Primary outcomes (1)
- measure
- Postoperative Pain Medication Use
- timeFrame
- Through 1 week postoperatively
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 or older 2. Diagnosed with prostate cancer 3. Electing to undergo robotic assisted laparoscopic prostatectomy (RALP) Exclusion Criteria: 1. Age \< 18 2. Emergency surgery 3. Patients with a significant preoperative dependence on narcotic medications 4. Unable to give informed consent 5. Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting 6. Persons participating in any other research study involving an investigational drug or device or investigational surgical procedure that could interfere with the physiologic parameters being collected (for example, a study evaluating different anesthesia regimens that could confound study results) 7. Non-English-speaking or reading
References
Publications (0)
Data not yet available