N/A
N=41
Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02262039 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Narcotic Use (mg) — 113.8; 99.6 mg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Valveless recirculating insufflation (VTI) (Device); Conventional pressure (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Use (mg) |
244.6; 234.0 | 0.78 |
| PRIMARY Narcotic Use (mg) |
244.6; 234.0 | 0.78 |
| PRIMARY Narcotic Use (mg) |
244.6; 234.0 | 0.78 |
| SECONDARY Subjective Pain Score |
3.9; 3.7 | 0.82 |
| SECONDARY Subjective Pain Score |
3.9; 3.7 | 0.82 |
| SECONDARY Subjective Pain Score |
3.9; 3.7 | 0.82 |
| SECONDARY Mean ETCO2 |
29.7; 30.8 | 0.45 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Any living donor who has been approved to donate a kidney is eligible to participate.
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT02262039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.