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The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.

NCT04755452 · Aalborg University Hospital · Updated 22 June 2023

What is being tested
Low intra-abdominal pressure; High (standard) intra-abdominal pressure
For
Acute Kidney Injury; Pneumoperitoneum; Kidney
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. About 100 people. The full rules are on the registry page.
Where
Denmark
When
Starts or started 23 Dec 2020, ends 28 Feb 2022. Registered 16 Feb 2021.
Results
None posted yet.

In the researchers' words

Within all the surgical specialties, major surgeries are performed whenever possible, as minimally invasive procedures to reduce blood loss, reduce pain and discomfort after surgery, avoid major scars, provide a faster recovery and thus shorter hospital stay. Such minimally invasive procedures in urinary tract surgeries are often performed as laparoscopic or robotic surgeries where CO2 (carbon dioxide) is insufflated into the abdominal cavity to create a working space for the surgeon's instruments. That high pressure created in the abdominal cavity (pneumoperitoneum) to create a workspace for the surgeon start a series of physiological changes in the heart, lung and kidney. Today, most laparoscopic, and robotic operations are performed with pneumoperitoneum of approximately 12-15 mm Hg, despite the fact that international guidelines recommend the use of the lowest intra-abdominal pressure (IAP) possible allowing adequate exposure of the operative field rather than using a routine pressure level. Investigator will conduct a randomized double-blind study involving 120 patients (2 groups of 60). The first group will be operated with standard pressure in the abdominal cavity 12-15 mm Hg (high IAP), patients in the second group will be operated on with a reduced pressure of ≈ 7 mmHg (low IAP). Investigator would like to assess the practical feasibility of operating under low…
ClinicalTrials.gov, NCT04755452

Sites

  • Aalborg university hospitalAalborg, North Jutland, Denmark