Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT06770803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
Official Title:
High Versus Low Pneumoperitoneum PressUre for Parenchymal Transection in Minimally Invasive Major Liver Surgery - a Non-inferiority, Multicenter, Randomized, Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPULS
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: