Impact of Using the Airseal System with Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: a Prospective, Comparative, Randomized Clinical Study. (ARCO2)

January 15, 2025 updated by: NILO JORGE CARVALHO LEÃO BARRETO, Brazilian Institute of Robotic Surgery
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the last decade, robot-assisted surgery has become one of the most popular surgical approaches worldwide. This minimally invasive surgery has gained notoriety mainly for reducing surgical time, having lower amounts of bleeding, among other benefits, resulting in fewer postoperative complications. However, patients with neoplasia usually have several comorbidities, and lower intra-abdominal pressure (IAP) during surgery is essential.

High-pressure pneumoperitoneum allows for a satisfactory working space and ideal visualization of the surgical field, shortening operative time and blood loss and, ultimately, improving surgical performance. On the other hand, however, several complications are related to the use of CO2, mainly in patients with compromised pulmonary and cardiac function. Innovative valveless low-pressure trocars, such as the AirSeal ® system (AirSeal®, ConMed, Utica, NY, USA), have been introduced and appear to be a valid alternative to the standard insufflation system based on preliminary studies. This system provides a more stable pneumoperitoneum, responding to minor changes in IAP, and is associated with a reduced rate of CO2 use, absorption, and elimination. Furthermore, CO2 use has been shown to be significantly reduced with this system, resulting in a potential reduction in CO2-related complications; this is particularly beneficial for patients with impaired cardiopulmonary function.

The AirSeal® platform has been evaluated in urological surgeries, mainly in cases of malignant disease. However, data demonstrating the potential benefits of its use are still lacking, which justifies the conduct of this research in order to add to this 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 prostate cancer patients 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 confirm the effectiveness and cost-benefit of using the AirSeal® system.

OBJECTIVES The objective is to compare intraoperative and postoperative complications in patients undergoing robot-assisted radical prostatectomy using AirSeal versus those who did not use AirSeal.

METHODOLOGY This is a prospective, randomized study with two comparative arms, whose subjects will undergo the procedures in a private institution in Salvador Bahia. It should last 1 year, with the start scheduled for June/2024. The population evaluated will be patients with prostate cancer who are scheduled for robotic-assisted prostatectomy to be performed by the team in question. All patients will be invited to participate in the study by signing the ICF. After signing, patients will be randomized to one of the two groups with a ratio of 1:1. The method chosen for this purpose will be randomization performed through sequential numbers kept in opaque, non-translucent and sealed envelopes, later drawn for random allocation into the groups. Randomization will be performed by the study coordinator. Randomization will be performed without the applicators of the postoperative scales knowing to which group the patients were allocated. According to the randomization, patients will be allocated to one of two groups: Group I (control): standard treatment and Group II (intervention): use of AirSeal.

A literature review will be conducted on the subject in question, seeking to add knowledge to this work. Perioperative outcomes will be compared between those who used AirSeal and those who used the standard insufflation system.

Data will be collected through patient records, in an electronic form and among the existing variables, we will address: console time; amount of blood loss; intra-abdominal pressure used and surgical complications. As well as postoperative complications: length of hospital stay; existence of paralytic ileus, pain complaints and postoperative complications. For all patients in both groups, pain levels will be measured using the verbal numeric scale (VNS) of pain in the immediate postoperative period (during post-anesthetic recovery) and then every 6 hours during the first 48 hours. The McGill Pain Questionnaire and the medication use questionnaire included in the protocol will also be administered once a week for the two weeks following the surgical procedure. In addition, the total use of opioids in both groups in the first 48 hours and in the two weeks following the procedure should be recorded. In addition, any complications and adverse effects of analgesia will be recorded. The EORTC QLQ-C30 questionnaire will be administered one week after surgery and data on postoperative ambulation will be assessed. All patients in both groups will receive a standard prescription for postoperative pain treatment according to the World Health Organization's analgesic pain scale. During hospitalization, all patients will be prescribed a mandatory systematic prescription of Dipyrone 1 gram every 6 hours intravenously. For patients allergic to Dipyrone, it should be replaced by Paracetamol 750mg every 6 hours orally. Other medications should be prescribed according to the level on the pain scale: if the pain is between 1 and 3, add Parecoxib 40 mg 24/24h to the prescription; if the pain is between 4 and 6, administer Tramadol 100 mg intravenously up to 6/6 hours; and if the pain is greater than or equal to 7, administer Morphine 2 mg 4/4 hours. At the time of hospital discharge, the patient should receive a prescription for home use of the simple analgesic that was used during hospitalization (dipyrone or paracetamol) if the pain is mild, and Tramadol 50 mg orally up to 6/6h for use if the pain is moderate or severe.

It is known that the use of opioids during surgery may also influence the control of postoperative pain, and with this in mind, there will be a standard protocol for the anesthetic procedure with standardization of medications used and their use according to the patient's weight and age.

Patients may request to be withdrawn from the study at any time. And participants will be screened according to the inclusion and exclusion criteria described below.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 43017030
        • Recruiting
        • Instituto Brasileiro de Cirurgia Robotica
        • Contact:
      • Salvador, Bahia, Brazil
        • Recruiting
        • Hospital Mater Dei Salvador
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Conventional Insufflator and Trocar
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
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.
Experimental: AirSeal® System-Interventional
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variance in Intra-abdominal Pressure with the AirSeal System
Time Frame: Day 1 (Day of Procedure)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Blood Loss with the AirSeal System
Time Frame: Day 1 (Day of Procedure)
This study will measure the total blood loss during the surgical procedure in patients using the AirSeal System versus those using the conventional insufflation system. Lower blood loss is hypothesized with the AirSeal System due to better surgical visibility and lower pressure variability.
Day 1 (Day of Procedure)
Length of Hospital Stay
Time Frame: Duration of hospital stay (up to 7 days)
The length of hospital stay will be recorded for all participants. Patients using the AirSeal System are expected to have a shorter hospital stay due to reduced complications and better recovery.
Duration of hospital stay (up to 7 days)
Incidence of Postoperative Complications
Time Frame: Up to 2 weeks post-procedure
Postoperative complications, including paralytic ileus, respiratory issues, and other adverse events, will be compared between the two groups. The AirSeal System is hypothesized to lower the incidence of these complications.
Up to 2 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilian Institute of Robotic Surgery

Collaborators

Hospital Mater Dei Salvador

Investigators

  • Principal Investigator: NILO J. MD, Brazilian Institute of Robotic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82409124.1.1001.5128

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Carcinoma

Clinical Trials on The Conventional Insufflation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe