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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Valveless recirculating insufflation (VTI); Device: Conventional pressure

• Registration Number: NCT02262039
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-07-09
• Study Start: 2014-08
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Results First Submitted: 2016-09-08
• Results First Submitted QC: 2016-10-31
• Results First Posted: 2016-12-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Read More

Exclusion Criteria

• none

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Pressure (VTI)	Valveless recirculating insufflation (VTI)	Valveless recirculating insufflation (VTI) with 10mmHg target pressure
Conventional Pressure	Conventional pressure	Conventional Insufflation with 15mmHg target pressure

Primary Outcome Measures

Name	Time	Method
Narcotic Use (mg)	Operative and Post-operative (until time of discharge, typically 2-4 days)	Total Morphine Equivalent - mean in mg

Secondary Outcome Measures

Name	Time	Method
Subjective Pain Score	12 hours post-op	Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Mean ETCO2	intraoperative	mean End-tidal carbon dioxide concentration in the expired air

Trial Locations

Locations (1)

Yale New Haven Transplantation Center; 🇺🇸 New Haven, Connecticut, United States