Activity Restrictions After Inguinal Hernia Repair

This study is looking at how different advice about activity restrictions after surgery for an inguinal hernia (a bulge in the groin area) affects your recovery. You would be assigned to one of two groups: a control group that follows standard activity precautions (6 weeks for open surgery, 2 weeks for minimally invasive surgery) or a treatment group that is told to "return to activity as tolerated/comfortable and stop activity if pain present." Researchers want to see if letting you decide when to return to activity helps you recover faster and if it affects complications or if the hernia comes back. This study is for adults aged 18 to 99 who have a single-sided inguinal hernia and are having surgery. The main goals are to see how often hernias come back after 2 years and to track complications for 2 months.

Study design
This is an interventional study with 200 participants. You would be randomly assigned to one of two groups.
What's involved
You would complete a questionnaire before surgery, undergo surgery, and then answer clinical questions and questionnaires during follow-up visits. Your medical charts will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for postoperative complications for 2 months and for hernia recurrence for 2 years.

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NCT05867134

Activity Restrictions After Inguinal Hernia Repair

Recruiting
NAAges 18–99InterventionalSupportive care
VA Eastern Colorado Health Care System
~200 participants
Updated 2023-05-19 on ClinicalTrials.gov
What's tested:Removal of postoperative lifting restrictions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Physiological parameter- Hernia recurrence
Measured over 2 years
+1 more outcome measured
Inguinal Hernia
1 sites across 1 states
Colorado1
  • Edward Jones · PRINCIPAL_INVESTIGATOR · VHAECH

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Eligibility criteria

Inclusion

Clinical diagnosis of unilateral inguinal hernia
Must be undergoing surgery
Must be able to consent

Exclusion

Bilateral inguinal hernia
Recurrent inguinal hernia
Surgery scheduled with additional concomitant procedures
  • Physiological parameter- Hernia recurrence2 years

    Study participants will be followed for 2 years following hernia surgery to evaluate for hernia recurrence in both study arms. Hernia recurrence would be determined by documentation in medical record by surgical teams.

  • Physiological parameter- Postoperative Complications2 months

    Study participants will be evaluated after 2 months for incidence of postoperative complication due to hernia surgery. This includes seroma, hematoma, bleeding, surgical site infection, and wound dehiscence. This will be obtained from participant medical record as documented by clinical providers, primary care providers, surgery, and emergency medicine.