Objective Measure of Recovery After Outpatient Surgery

Completed

• Conditions: Hernia, Inguinal; Convalescence
• Interventions: Device: GENEactiv

• Registration Number: NCT02616406
• Lead Sponsor: Mayo Clinic

Brief Summary

This is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients presenting for outpatient inguinal hernia repair without significant medical comorbidities
• Patients who consent to participating and willing to wear device for designated time period per protocol

Exclusion Criteria

• History of chronic opioid use
• Inability to speak English
• Inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic group	GENEactiv	Laparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op.
Open repair	GENEactiv	Repair group to be monitored with wearable activity monitors pre and post op.

Primary Outcome Measures

Name	Time	Method
Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.	8 weeks

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States