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OpenTrials
Completed

NCT Number: NCT02616406

Objective Measure of Recovery After Outpatient 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.

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Key information

Conditions

Hernia, Inguinal Convalescence Disease Attributes Hernia Hernia, Abdominal Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GENEactiv

Device

To wear a monitoring device for a period of time prior to surgery and post surgery

Primary outcomes

  1. Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement.

    Time frame: 8 weeks

Secondary outcomes

  1. Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2015
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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