Minimally invasive techniques in liver surgery gain popularity as they facilitate postoperative recovery while achieving comparable oncologic outcomes to the open approach. No consensus on the application of pneumoperitoneum pressure in minimal invasive liver resections (MILR) has been reached yet, as prospective clinical studies are scarce. The positive pressure of the CO2 pneumoperitoneum reduces intraoperative blood loss during MILR alongside the development of new transection devices and advancements in inflow control. Low-pressure pneumoperitoneum on the other hand has been shown to decrease postoperative pain scores and analgesic consumption in comparison to standard pneumoperitoneum, and international guidelines recommend the application of "the lowest intra-abdominal pressure allowing adequate exposure of the operative field rather than a routine pressure". Nevertheless, evidence for the application of low-pressure pneumoperitoneum is only moderate to low, requiring additional studies to better define its safety. To address this oxymoron, the investigators conduct a randomized non-inferiority trial to investigate the effect of low in comparison to high-pressure pneumoperitoneum during the transection phase of major MILR on intraoperative blood loss while also evaluating the risk of embolic complications.
age equal or older than 18 years and
capacity of consent and
planned elective conventional laparoscopic or da Vinci-assisted major liver resection or resections near the liver hilum or the hepatic venous vasculature. Major liver resections are defined as the resection of 3 liver segments or more (right and left partial hepatectomies, extended right and left hepatectomies, liver resections of 3 or more segments). Right posterior sectionectomies and mesohepatectomies of ≥2 liver segments are considered resections in proximity to the liver hilum or hepatic venous vasculature.
the participation in another trial with interference of intervention and outcome of this study,
being a woman who is pregnant or breast-feeding or planning to become pregnant,
American Society of Anesthesiologists (AS) score >3,
language barrier,
Parallel
High Pressure Pneumoperitoneum
Procedure/SurgeryThe objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.
Low Pressure Pneumoperitoneum
Procedure/SurgeryThe objective of this trial is to determine whether the maintenance of a low intraperitoneal insufflation pressure (IIP) of ≤10 mmHg during the parenchymal transection phase of conventional and robotic-assisted laparoscopic liver resection is non-inferior to a higher IIP of ≥14 mmHg in terms of intraoperative blood loss, gas embolisms, perioperative morbidity, and mortality.
Intraoperative blood loss
Incidence of CO2 embolisms
Incidence of CO2 embolisms in the right atrioventricular system detected by intraoperative transesophageal echocardiography
Morbidity rate
Postoperative complication rate
Mortality rate
Postoperative mortality
Click on the lead sponsor to view all of their trials.
University Hospital Heidelberg
Lead sponsor
University of Ulm
Collaborator
University Hospital Dresden
Collaborator
Groeninge Hospital, Kortrijk, Belgium
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
