Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Kidney Injury
  • Kidney
  • Pneumoperitoneum
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

Description

A total of 120 patients between the ages of 18 and 80 years who were scheduled for elective robotic radical nephrectomy will included in the study. This is randomized controlled double-blind clinical trial. A standard anesthesia protocol will be used in both groups. Bladder catheter inserted by the ...

A total of 120 patients between the ages of 18 and 80 years who were scheduled for elective robotic radical nephrectomy will included in the study. This is randomized controlled double-blind clinical trial. A standard anesthesia protocol will be used in both groups. Bladder catheter inserted by the OP-nurse. After ports installment under IAP of 7 mm Hg, the surgeon leaves the operation field and sits at a surgical console. The ground nurse opens the sealed letter which indicated the pressure for operation (electronic randomization was previously performed by investigator using https://www.graphpad.com/quickcalcs/index.cfm) The required IAP sets by the ground nurse before the surgery started. Assistants are not blinded in the study, but the surgeon is. Intra-abdominal pressure will be maintained at 7 mmHg in Group Low IAP and at 12 mmHg in Group High IAP throughout the surgery. If under operation the surgeon required to raise the IAP because of bad views, or bleeding, he/she can always ask the ground nurse to raise the pressure by 2- or 3-mm Hg at a time until surgeon obtain the preferred view. This involved both groups. Patient will not be excluded from study if pressure increased, but the duration of raised IAP will be registered. During the operation, the surgical working space will be evaluated by surgeon using an adopted version of SRS (Surgical rating scale). 1st time during mobilization of bowel, 2nd time during renal vascular dissection, and last time when surgeon remove the kidney and set it in the Endobag. All patients asked to register their 24-hour urine production before the operation day. Intra-operative urine output will be also registered. 10 ml urine will be collected 3 times in order to investigate the risk of Acute Kidney Injury (AKI) by kidney injury biomarker (u-NGAL, og KIM-1). Pre-operatively during urinary catheter placement, 2-hour post-operatively, and 24 hours after operation. Urine samples collected and stored in -80 C for later analyses. Investigator will test the quality of recovery using a validated Quality of recovery-15 (QoR-15) questionnaire before the surgery and at day 1,3,14,30 post-op.

Tracking Information

NCT #
NCT04755452
Collaborators
Not Provided
Investigators
Principal Investigator: Hayder Al-husseinawi, M.D. Aalborg University Hospital