Activity Restrictions After Inguinal Hernia Repair

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Behavioral: Removal of postoperative lifting restrictions

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward Jones; Phone Number: 7207236462; Email: edward.jones@cuanschutz.edu
• Study Contact Backup: Name: Danielle Abbitt; Email: danielle.abbitt@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Rocky Mountain Regional VA Medical Center
      • Contact: Edward L Jones, MD; Phone Number: 720-723-6462; Email: Edward.Jones1@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activity as tolerated; Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".	Behavioral: 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".
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Investigators: Principal Investigator: Edward Jones, VHAECH

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: hernia, recovery, surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 1610664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No