Hernia, InguinalNCT02616406
Objective Measure of Recovery After Outpatient Surgery
An observational study of Hernia, Inguinal and Convalescence, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Inguinal, Convalescence
- What is being tested?
- GENEactiv
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with inguinal hernia who are to have hernia repair
Who may be able to join
- 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
Who cannot join
- History of chronic opioid use
- Inability to speak English
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hernia, Inguinal, Convalescence
- Being tested
- GENEactiv
- Keywords
- recovery of function
- Medical subject headings
- Hernia, Inguinal, Convalescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENEactivDevice
To wear a monitoring device for a period of time prior to surgery and post surgery
| Study group | Role | What they receive |
|---|---|---|
| Open repair | Repair group to be monitored with wearable activity monitors pre and post op. Receives: Device: GENEactiv | |
| Laparoscopic group | Laparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op. Receives: Device: GENEactiv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement.
Measured: 8 weeks
Secondary outcomes (1)
Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Karl A. Poterack, M.D., Mayo Clinic
- Investigators
- Karl A. Poterack, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616406
- Sponsor's protocol ID
- 15-001248
- Status last verified
- Aug 2022
- First submitted
- 20 Nov 2015
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Activity to Determine When Patients Return to Baseline Levels of Activity Following Outpatient Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT02616406
- Acronym / sponsor ID
- 15-001248
- Conditions
- Hernia, Inguinal, Convalescence
- Keywords
- recovery of function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open repair | – | Device: GENEactivRepair group to be monitored with wearable activity monitors pre and post op. |
| Laparoscopic group | – | Device: GENEactivLaparoscopic surgical repair group to be monitored with wearable activity monitors pre and post op. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with inguinal hernia who are to have hernia repair
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- History of chronic opioid use
- Inability to speak English
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENEactivTo wear a monitoring device for a period of time prior to surgery and post surgery | Device | Laparoscopic group, Open repair |
Primary outcome
Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement.
Time frame: 8 weeks
1 secondary outcome
Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl A. Poterack, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal and Convalescence, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.