Recruiting

Observational Study

Sponsor:

VA Eastern Colorado Health Care System

Code:

NCT05867134

Conditions

Inguinal Hernia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Removal of postoperative lifting restrictions

Study Details

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

Study ID

NCT05867134

Start date

Jan 30, 2023

Status verified date

May, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Activity as tolerated

Instruction will be a treatment group "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".

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".

Primary outcome measure

  • Physiological parameter- Hernia recurrence [ Time Frame: 2 years ]
  • Physiological parameter- Postoperative Complications [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Edward Jones

7207236462edward.jones@cuanschutz.edu

Danielle Abbitt

danielle.abbitt@cuanschutz.edu

Locations

Rocky Mountain Regional VA Medical Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Edward L Jones, MD

720-723-6462Edward.Jones1@va.gov

More Information

Sponsor

VA Eastern Colorado Health Care System

Last update posted

May 19, 2023

Last verified

May, 2023

Keywords

  • hernia, recovery, surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System on 2023-05-19.