Activity Restrictions After Inguinal Hernia Repair

Not Applicable

Recruiting

• Conditions: Inguinal Hernia
• Interventions: Behavioral: Removal of postoperative lifting restrictions

• Registration Number: NCT05867134
• Lead Sponsor: VA Eastern Colorado Health Care System

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.

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-01-30
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity as tolerated	Removal of postoperative lifting restrictions	Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".

Primary Outcome Measures

Name	Time	Method
Physiological parameter- Hernia recurrence	2 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 Complications	2 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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire- Postoperative Activity levels	6 weeks	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.

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center; 🇺🇸 Aurora, Colorado, United States