Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System
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Details and patient eligibility
About
The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.
Full description
Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.
The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.
Enrollment
Sex
Volunteers
Inclusion criteria
- Any living donor who has been approved to donate a kidney is eligible to participate.
Exclusion criteria
- none
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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