Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:Any
Updated:1/19/2018
Start Date:August 2014
End Date:February 2016

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Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial

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.

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.

Inclusion Criteria:

- Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion Criteria:
We found this trial at
1
site
New Haven, Connecticut 06520
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mi
from
New Haven, CT
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