NCT02616406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

November 20, 2015

Last Update Submit

August 8, 2022

Conditions

Hernia, InguinalConvalescence

Keywords

recovery of function

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (2)

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

GENEactivDEVICE

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

Laparoscopic groupOpen repair

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with inguinal hernia who are to have hernia repair

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Hernia, InguinalConvalescence

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Karl A. Poterack, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

US(1)