Activity Restrictions After Inguinal Hernia Repair

NCT ID: NCT05867134

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

This study will evaluate lifting restrictions in the postoperative period after inguinal hernia repair. Patients will be consented to the study via in person and electronic methods. Patients will be asked to answer a questionnaire regarding their current pre-operative activity levels in order to establish a baseline. Patients will undergo surgery according to normal medical recommendations and patient preference. 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". Patients will be observed in post-operative clinics and asked clinical questions, as well as questionnaires to assess their surgical experience, when they returned to activity, and overall quality of life. Medical charts will be reviewed in order to compare differences in responses and behaviors between the two groups and these data points will be recorded in a password protected document for data analysis.

This study aims to identify if lengthy recommendations for convalescence after inguinal hernia surgery are necessary and determine the impact of allowing the individual patient to have some autonomy in a recommendation to return to physical activity based on their own comfort level. This study could provide the surgical community with a more structured response after this common surgical procedure, as well as potentially reduce convalescence times for individual patients, leading to less economic burden on the individual and the community with returning to work precautions.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Activity as tolerated

Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".

Group Type: EXPERIMENTAL

Removal of postoperative lifting restrictions

Intervention Type: 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".

Standard Lifting Restrictions

Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Removal of postoperative lifting restrictions

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".

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Bilateral inguinal hernia
• Recurrent inguinal hernia
• Surgery scheduled with additional concomitant procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Eastern Colorado Health Care System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Jones

Role: PRINCIPAL_INVESTIGATOR

VHAECH

Locations

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edward Jones

Role: CONTACT

edward.jones@cuanschutz.edu

7207236462

Danielle Abbitt

Role: CONTACT

danielle.abbitt@cuanschutz.edu

Facility Contacts

Edward L Jones, MD

Role: primary

Edward.Jones1@va.gov

720-723-6462

Other Identifiers

1610664

Identifier Type: -

Identifier Source: org_study_id