Objective Measure of Recovery After Outpatient Surgery | NCT02616406

Studies
Objective Measure of Recovery After Outpatient Surgery

NCT02616406

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Aug 10, 2022Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Hernia, Inguinal
Convalescence

Interventions

GENEactiv

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Jul 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Nov 20, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2022

Last Update Posted Date

Aug 10, 2022Actual

Name	Class
Arizona State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open repair		Repair group to be monitored with wearable activity monitors pre and post op.	Device: GENEactiv
Laparoscopic group		Laparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op.	Device: GENEactiv

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GENEactiv	Device	To wear a monitoring device for a period of time prior to surgery and post surgery	Laparoscopic group Open repair

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adults with inguinal hernia who are to have hernia repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl A. Poterack, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D003289	Convalescence

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided