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NCT02616406 Clinical Trial

Objective Measure of Recovery After Outpatient Surgery

Hernia, Inguinal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02616406
Other study ID # 15-001248
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date July 2019

Study information
Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• GENEactiv
To wear a monitoring device for a period of time prior to surgery and post surgery

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Arizona State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine time of return to baseline activity following elective outpatient hernia repair using wearable accelerometers that measure physical movement. 8 weeks
Secondary Determine pain levels on visual analog scale after outpatient hernia repair via telephonic questionnaire. 8 weeks
See also
  Status Clinical Trial Phase
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Completed NCT00130091 - The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children Phase 2
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
Recruiting NCT03041948 - Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair N/A
Completed NCT02751190 - Chronic Pain After Groin Hernia Repair N/A
Completed NCT04228536 - Chronic Pain After Groin Hernia Surgery in Women
Completed NCT04839848 - Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
Recruiting NCT02011698 - Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial N/A
Completed NCT00749268 - AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair Phase 4
Completed NCT00827944 - Parietex Progrip Study Phase 4
Recruiting NCT03673163 - Lidocaine Infusion for Pain After Herniotomy N/A
Terminated NCT00735124 - Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy Phase 2/Phase 3
Recruiting NCT05323552 - Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.
Completed NCT03326700 - Effects of Hernia Repair on Men's Sexual Functions N/A
Recruiting NCT05839587 - Transabdominal Preperitoneal Inguinal Hernia Repair N/A
Completed NCT03392636 - Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years N/A
Completed NCT05600296 - Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block Phase 1
Recruiting NCT05280860 - Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery N/A

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