Clinical trial NCT05867134: Activity Restrictions After Inguinal Hernia Repair
Official title: Activity Restrictions After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: hernia, recovery, surgery
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2023-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Physiological parameter- Hernia recurrence
timeFrame: 2 years
measure: Physiological parameter- Postoperative Complications
timeFrame: 2 months
Secondary outcomes:
measure: Questionnaire- Postoperative Activity levels
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
Study officials:
affiliation: VHAECH
name: Edward Jones
role: PRINCIPAL_INVESTIGATOR
References: