Clinical trial NCT06784986: Impact of Using the Airseal System with Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: a Prospective, Comparative, Randomized Clinical Study.
Official title: Impact of Using the Airseal System with Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: a Prospective, Comparative, Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostate Carcinoma
Prostate Neoplasm
Pain Intensity Assessment
Quality of Life (QOL)
Keywords: pneumoperitoneum
airseal
pneumoperitoneum in prostate neoplasm
Lead sponsor: Brazilian Institute of Robotic Surgery
Sponsor class: OTHER
Collaborators: name: Hospital Mater Dei Salvador
First posted: 2025-01-20
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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, metastasis and other existing neoplasms.

Primary outcomes:
measure: Variance in Intra-abdominal Pressure with the AirSeal System
timeFrame: Day 1 (Day of Procedure)
Secondary outcomes:
measure: Reduction in Blood Loss with the AirSeal System
timeFrame: Day 1 (Day of Procedure)
measure: Length of Hospital Stay
timeFrame: Duration of hospital stay (up to 7 days)
measure: Incidence of Postoperative Complications
timeFrame: Up to 2 weeks post-procedure
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Instituto Brasileiro de Cirurgia Robotica
state: Bahia
city: Salvador
country: Brazil
facility: Hospital Mater Dei Salvador
state: Bahia
Study officials:
affiliation: Brazilian Institute of Robotic Surgery
name: NILO J. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.