Activity Restrictions After Inguinal Hernia Repair

Part of paid clinical trials in Aurora, Colorado.

Sponsor
VA Eastern Colorado Health Care System
Study ID
NCT05867134
Status
Recruiting
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Conditions

  • Inguinal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Removal of postoperative lifting restrictions — BEHAVIORAL
    Patients will be randomized into one of two groups: a control group told to practice standard of care at Eastern Colorado VA with return to activity precautions (6 weeks for open surgery, 2 weeks for minimally invasive surgery) and a treatment group told to "return to activity as tolerated/comfortable and stop activity if pain present".

Study Details

This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.

Key Dates

Start date
Jan 30, 2023
Status verified
May 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Activity as tolerated
    Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".
  • No Intervention: Standard Lifting Restrictions
    Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".

Primary Outcome Measure

Physiological parameter- Hernia recurrence [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical CenterAuroraColorado80045
Edward L Jones, MD
[email protected]
720-723-6462

Find similar trials in Aurora, CO

By research site
Rocky Mountain Regional VA Medical Center· Aurora, CO

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