Activity Restrictions After Inguinal Hernia Repair

NCT05867134 | Recruiting

• 1 other identifier: 1610664
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

hernia, recovery, surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Questionnaire- Postoperative Activity levels

  6 weeks

Study Arms (2)

Activity as tolerated

EXPERIMENTAL

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

Behavioral: Removal of postoperative lifting restrictions

Standard Lifting Restrictions

NO INTERVENTION

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

Interventions

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".

Activity as tolerated

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Jones

  VHAECH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Jones

CONTACT

7207236462; edward.jones@cuanschutz.edu

Danielle Abbitt

CONTACT

danielle.abbitt@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: May 19, 2023
• Study Start: January 30, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)