Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID05867134

Activity Restrictions After Inguinal Hernia Repair

Led by VA Eastern Colorado Health Care System · Updated on 2023-05-19

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of different physical activity guidelines following surgery for single-sided inguinal hernia repair. This pilot study compares outcomes between patients given standard lifting restrictions and those allowed to return to activity based on their comfort. The goal is to see if allowing patient autonomy can reduce recovery time while monitoring complications, hernia recurrence, physical activity levels, and quality of life. Participants will be randomly assigned to one of two groups after surgery: a control group following standard precautions (lifting no more than 20 pounds for 6 weeks after open surgery or 2 weeks after minimally invasive surgery), or a treatment group advised to resume activities as tolerated but to stop if pain occurs. Surgery will be performed according to usual medical care. Data will be collected through pre- and post-operative questionnaires, clinical visits, and medical chart reviews. Throughout the study, participants will be assessed on their surgical recovery, timing of return to physical activity, and overall quality of life. Researchers will monitor hernia recurrence and post-surgery complications for up to two years. Questionnaires about activity levels will be completed within six weeks after surgery. All data will be securely stored and analyzed to compare outcomes between the two groups.

CONDITIONS

Brief Title

Activity Restrictions After Inguinal Hernia Repair

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of unilateral inguinal hernia
  • Scheduled to undergo surgery
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Bilateral inguinal hernia
  • Recurrent inguinal hernia
  • Surgery planned with additional procedures besides hernia repair

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or electronic)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo inguinal hernia repair surgery followed by immediate postoperative care according to normal medical recommendations.

1 visit (in-person surgical procedure)

Outpatient Treatment

Duration - Up to 6 weeks depending on surgery type and treatment group

Participants follow either standard lifting restrictions or return to activity as tolerated instructions during recovery after surgery.

Multiple outpatient visits for post-operative clinical assessments and questionnaires

Follow-up

Duration - Up to 2 years

Participants are observed for postoperative complications and hernia recurrence to assess long-term outcomes.

Periodic clinic visits and questionnaires over 2 years

Trial Site Locations

Total: 1 location

1

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

E

Edward Jones

D

Danielle Abbitt

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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