Objective Measure of Recovery After Outpatient Surgery

August 8, 2022 updated by: Karl A. Poterack, M.D., Mayo Clinic

Assessment of Physical Activity to Determine When Patients Return to Baseline Levels of Activity Following Outpatient Inguinal Hernia Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with inguinal hernia who are to have hernia repair

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open repair
Repair group to be monitored with wearable activity monitors pre and post op.
Device: GENEactiv
To wear a monitoring device for a period of time prior to surgery and post surgery
Laparoscopic group
Laparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op.
Device: GENEactiv
To wear a monitoring device for a period of time prior to surgery and post surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Arizona State University

Investigators

  • Principal Investigator: Karl A. Poterack, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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