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Objective Measure of Recovery After Outpatient Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02616406
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Karl A. Poterack, M.D., 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.

Condition or disease Intervention/treatment
Hernia, Inguinal Convalescence Device: GENEactiv

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Physical Activity to Determine When Patients Return to Baseline Levels of Activity Following Outpatient Inguinal Hernia Surgery
Study Start Date : November 2015
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with inguinal hernia who are to have hernia repair
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616406


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Arizona State University
Investigators
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Principal Investigator: Karl A. Poterack, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Karl A. Poterack, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02616406    
Other Study ID Numbers: 15-001248
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Keywords provided by Karl A. Poterack, M.D., Mayo Clinic:
recovery of function
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Convalescence
Pathological Conditions, Anatomical
Hernia, Abdominal
Disease Attributes
Pathologic Processes