Journal of Clinical Trials
Open Access

Abstract

Low Pressure Pneumoperitoneum and Deep Neuromuscular Block Versus Standard Laparoscopy during Robot Assisted Radical Prostatectomy to Improve the Quality of Recovery and Immune Homeostasis: Study Protocol for a Randomized Controlled Study

G.T.J.A. Reijnders-Boerboom*, J.P. van Basten, L.M.C. Jacobs, M. Brouwer, M. van Dijck, K.I Albers, I.F. Panhuizen, G.J. Scheffer, C. Keijzer and M.C. Warlé

Background: A pneumoperitoneum with Carbon Dioxide (CO₂) is required to obtain an adequate surgical field for laparoscopic surgery, including Robot Assisted Radical Prostatectomy (RARP). Nevertheless, the use of an increased Intra-Abdominal Pressure (IAP) may have a negative impact on the quality of recovery after surgery. IAP causes a temporary decrease in the perfusion of surrounding tissues leading to ischemia-reperfusion injury with oxidative stress and release of Danger Associated Molecular Patterns (DAMPs). Thereby contributing to pain and inflammation which has a negative impact on the quality of recovery. With accumulating evidence demonstrating the safety and advantages of low-pressure IAP (6-8 mmHg), such as reduction in postoperative pain, opioid consumption, improved bowel function recovery, a reduced inflammatory response and preserving innate immune function, this study is designed to unravel the link between the degree of IAP, parietal peritoneal perfusion, innate immune function, and the quality of recovery after RARP.

Methods: This is a blinded randomized controlled trial comparing ‘standard laparoscopy’, consisting of standard IAP (14 mmHg) with moderate Neuromuscular Blockade (NMB) and low IAP (8 mmHg) with deep NMB. All patients will receive surveys focused on recovery on three time points. For inflammatory response and innate immune function blood samples and biopsies will be taken and for imaging of the peritoneal perfusion, indocyanine green injection will be given after which a recording will be collected for further analysis.

Discussion: There is increasing evidence of the benefits of low IAP, although there is limited evidence on low pressure RARP. Studies indicate that mainly prolonged, high intra-abdominal pressures lead to ischemia-reperfusion injury and oxidative stress. Recent studies with low-pressure RARP reported a shorter length of hospital stay and less readmission within 30 days. Furthermore, it is important to maintain an adequate neuromuscular block during laparoscopic procedures at low pressure, as insufficient surgical conditions may hamper patient safety. Deep NMB itself may also contribute to improved postoperative outcomes with lower postoperative pain scores and analgesic requirement. Therefore, we hypothesize that ‘low impact laparoscopy’, defined as the combination of low IAP (<10 mmHg) facilitated with deep NMB, could be beneficial to improve the quality of postoperative recovery after RARP.

Trial registration: Clinicaltrials.gov (NCT04250883 (RECOVER2)).

Published Date: 2021-12-07; Received Date: 2021-11-16