The target population for this study consists of all patients undergoing kidney surgery at Haukeland University Hospital, Norway, with the primary focus being patients undergoing robot-assisted partial nephrectomy.
The study has two main objectives. First, the investigators aim to assess whether a flank approach to robot assisted partial nephrectomy may be superior to a trans abdominal approach with regard to postoperative pain, recovery, and quality of life. Second, while conducting this study, the investigators also seek to compare two methods of renal artery clamping during the partial nephrectomy procedure. Specifically, the investigators aim to determine whether a technique that reduces the duration of ischemia can be performed without causing an unacceptable increase in blood loss or postoperative complications.
Signed written informed consent obtained prior to any study specific procedures
Patient must be willing and able to comply with the protocol
Age >18
Patients scheduled for robot-assisted partial kidney resection with either the trans- or retroperitoneal access
Previous kidney surgery on the affected side
Preexisting extensive intraabdominal adhesions preventing the use of the transabdominal access
Preexisting severe pain condition requiring regular use of opioids adding up to more than equivalent of 10mg po morphine daily
Any other physical or mental illness that according to the treating surgeon makes the patient unfit for inclusion in the study
Parallel
Standard clamping strategy
Procedure/SurgeryPatients randomized to standard declamping will have the clamp on until tumour resection, renorraphy and adaptation of the resection surfaces is performed
Early declamping strategy
Procedure/SurgeryThe patients randomized to early declamping strategy will have the clamp on until tumour resection and ranorraphy is completed, but the clamp is removed before adaptation of the resection surfaces is performed
Change in Brief Pain Inventory (BPI) pain severity score from baseline to postoperative day
Pain severity will be assessed using the Brief Pain Inventory. The scale measures the patients subjective assessment of pain on 15 different items. The scale ranges from 0 to 10, where 0 indicates no pain, and 10 indicates worst thinkable pain. The outcome measure will be calculated as the change from baseline to postoperative day 1 using the mean score of items 3-6.
Intraoperative blood loss during robot-assisted partial nephrectomy
Blood loss will be measured intraoperatively in milliliters and compared between early and standard renal artery declamping strategies.
Total opioid consumption during the first 24 postoperative hours
Opioid administration will be converted to oral morphine equivalents and summed over the first 24 hours after surgery.
Change in Quality of Recovery-15 Norwegian version (QoR-15NO) score
Recovery will be assessed using Quality of recovery 15, Norwegian version (QoR-15NO). The scale measures recovery after surgery on a 15 item scale ranging from 0 to 10 where 0 is worst possible recovery, and 10 is best possible recovery. The outcome measure will be the change from baseline to postoperative day 1, at 6 weeks, and 1 year after surgery.
Change in the European Organisation for Research and Treatment of Cancer quality of life 30 (EORTC QLQ 30)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer quality of life 30 (EORTC QLQ 30) questionnaire. The scale measures quality of life on a 30 item scale on a range of 1 to 4 ( 1 to seven regarding items 29 and 30), where 1 is best quality of life, and 4 is worst.
Warm ischemia time during robot-assisted partial nephrectomy
Warm ischemia time will be measured in minutes from application to removal of the renal artery clamp.
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Bjarte Almas
Lead sponsor
Haukeland University Hospital
Sponsor institution
Haukeland University Hospital, Bergen, Norway
Collaborator
University of Bergen
Collaborator
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