Health TrialsbyHealthPanel

Activity Restrictions After Inguinal Hernia Repair

ConditionInguinal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorVA Eastern Colorado Health Care System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Clinical diagnosis of unilateral inguinal hernia

Must be undergoing surgery

Must be able to consent

Disqualifiers

Bilateral inguinal hernia

Recurrent inguinal hernia

Surgery scheduled with additional concomitant procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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".

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Activity as toleratedExperimental treatment 1 intervention
Group B: Standard Lifting RestrictionsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Physiological parameter- Hernia recurrence

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.

Time frame
2 years
2

Physiological parameter- Postoperative Complications

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.

Time frame
2 months

Secondary outcomes

1

Questionnaire- Postoperative Activity levels

Following surgery, study participants will follow specified activity restrictions (per study arm). At the 6 week mark after surgery, participants will complete a survey asking for quantification of vigorous, moderate, walking and sitting activities. Surveys include description of each activity.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Eastern Colorado Health Care System

Lead sponsor

Source ClinicalTrials.gov
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