Clinical trial · Interventional
Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
- 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 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 pneumoperitoneum with the AirSeal system in patients with prostate cancer undergoing robot-assisted prostatectomy with those undergoing the procedure with the conventional insufflation system. We seek to provide more data on the use of AirSeal, which is associated with shorter operative times, shorter hospital stays and a lower probability of complications. In addition, we aim to ratify the effectiveness and cost-benefit of using the AirSeal system.
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 |
|---|---|---|---|
| Pain Intensity Assessment | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life (QOL) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AirSeal® System | Device | — | UNRESOLVED |
| The Conventional Insufflation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Conventional Insufflator and Trocar
- description
- Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using a conventional CO2 insufflation system. This system maintains standard intra-abdominal pressure (12-15 mmHg) and is widely used in clinical practice.
- interventionNames
- Device: The Conventional Insufflation System
- type
- EXPERIMENTAL
- label
- AirSeal® System-Interventional
- description
- Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using the AirSeal® System. The device enables stable pneumoperitoneum at ultra-low pressures (6-8 mmHg), aiming to reduce complications and improve surgical outcomes.
Primary outcomes (1)
- measure
- Variance in Intra-abdominal Pressure with the AirSeal System
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (6)
- RESULTRazdan S, Ucpinar B, Okhawere KE, Badani KK. The Role of AirSeal in Robotic Urologic Surgery: A Systematic Review. J Laparoendosc Adv Surg Tech A. 2023 Jan;33(1):21-31. doi: 10.1089/lap.2022.0153. Epub 2022 Jun 7. PMID 35671523
- RESULTHorstmann M, Horton K, Kurz M, Padevit C, John H. Prospective comparison between the AirSeal(R) System valve-less Trocar and a standard Versaport Plus V2 Trocar in robotic-assisted radical prostatectomy. J Endourol. 2013 May;27(5):579-82. doi: 10.1089/end.2012.0632. Epub 2013 Feb 5. PMID 23186377
- RESULTFeng TS, Heulitt G, Islam A, Porter JR. Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial. J Robot Surg. 2021 Jun;15(3):381-388. doi: 10.1007/s11701-020-01117-z. Epub 2020 Jul 6. PMID 32632561
- RESULTBhat KRS, Raghunath SK, Srivatsa N, Tejus C, Vishruth K, Kumar RA. Outcomes of Minimally Invasive Radical Prostatectomy-a Contemporary Review. Indian J Surg Oncol. 2020 Dec;11(4):580-588. doi: 10.1007/s13193-020-01125-3. Epub 2020 Jun 11. PMID 33299276
- RESULTBalayssac D, Selvy M, Martelin A, Giroudon C, Cabelguenne D, Armoiry X. Clinical and Organizational Impact of the AIRSEAL(R) Insufflation System During Laparoscopic Surgery: A Systematic Review. World J Surg. 2021 Mar;45(3):705-718. doi: 10.1007/s00268-020-05869-5. Epub 2020 Nov 30. PMID 33258023
- DERIVEDHe J, Pan X. Carbon dioxide laparoscopic technology: research hotspots and innovations in pneumoperitoneum detection. Med Gas Res. 2026 Dec 1;16(4):415-425. doi: 10.4103/mgr.MEDGASRES-D-25-00206. Epub 2026 Mar 26. PMID 41888042