Impact of Using the Airseal System with Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: a Prospective, Comparative, Randomized Clinical Study.

NCT06784986 | Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 82409124.1.1001.5128
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Prostate Carcinoma; Prostate Neoplasm; Pain Intensity Assessment; Quality of Life (QOL)

Keywords

pneumoperitoneum; airseal; pneumoperitoneum in prostate neoplasm

Outcome Measures

Primary Outcomes (1)

• Variance in Intra-abdominal Pressure with the AirSeal System

  The primary aim of this study is to compare the variance in intra-abdominal pressure (IAP) during robotic-assisted radical prostatectomy between patients using the AirSeal System and those using a conventional CO2 insufflation system. The AirSeal System is expected to provide a more stable IAP at ultra-low pressures (6-8 mmHg) compared to the standard pressures (12-15 mmHg) maintained by the conventional insufflator.

  Day 1 (Day of Procedure)

Secondary Outcomes (3)

• Reduction in Blood Loss with the AirSeal System

  Day 1 (Day of Procedure)

• Length of Hospital Stay

  Duration of hospital stay (up to 7 days)

• Incidence of Postoperative Complications

  Up to 2 weeks post-procedure

Study Arms (2)

Conventional Insufflator and Trocar

OTHER

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.

Device: The Conventional Insufflation System

AirSeal® System-Interventional

EXPERIMENTAL

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.

Device: AirSeal® System

Interventions

The Conventional Insufflation System DEVICE

The Conventional Insufflation System employs standard CO2 insufflation techniques for maintaining intra-abdominal pressure during laparoscopic and robotic surgeries. It serves as the base for comparison with the AirSeal® System.

Conventional Insufflator and Trocar

AirSeal® System DEVICE

The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple-lumen filtered tube set, and a valve-free trocar (AirSeal® Access Port). This innovative system allows peritoneal access and pneumoperitoneum maintenance without a mechanical seal, reducing CO2 usage and associated complications.

AirSeal® System-Interventional

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate cancer who will undergo robotic prostatectomy;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brazilian Institute of Robotic Surgery: lead
• Hospital Mater Dei Salvador: collaborator

Study Sites (2)

Instituto Brasileiro de Cirurgia Robotica

Salvador, Estado de Bahia, 43017030, Brazil

RECRUITING

Hospital Mater Dei Salvador

Salvador, Estado de Bahia, Brazil

RECRUITING

Related Publications (5)

• Razdan 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 BACKGROUND

• Horstmann 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 BACKGROUND

• Feng 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 BACKGROUND

• Bhat 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 BACKGROUND

• Balayssac 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Officials

• NILO J. MD

  Brazilian Institute of Robotic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NILO JORGE LEÃO COORDENADOR

CONTACT

+55 71 2626-3030; ibcrpesquisa@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: February 15, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

BR (2)