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Activity Restrictions After Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Removal of postoperative lifting restrictions
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inguinal Hernia focused on measuring hernia, recovery, surgery

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rocky Mountain Regional VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Activity as tolerated

Standard Lifting Restrictions

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2023
Last Updated
May 16, 2023
Sponsor
VA Eastern Colorado Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT05867134
Brief Title
Activity Restrictions After Inguinal Hernia Repair
Official Title
Activity Restrictions After Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Eastern Colorado Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
hernia, recovery, surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activity as tolerated
Arm Type
Experimental
Arm Description
Instruction will be a treatment group "return to activity as tolerated/comfortable and stop activity if pain present".
Arm Title
Standard Lifting Restrictions
Arm Type
No Intervention
Arm Description
Instructions will be "no lifting greater than 20lbs for 6 weeks for open surgery, 2 weeks for minimally invasive surgery".
Intervention Type
Behavioral
Intervention Name(s)
Removal of postoperative lifting restrictions
Intervention Description
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 Information:
Title
Physiological parameter- Hernia recurrence
Description
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.
Time Frame
2 years
Title
Physiological parameter- Postoperative Complications
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Questionnaire- Postoperative Activity levels
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Jones
Phone
7207236462
Email
edward.jones@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Abbitt
Email
danielle.abbitt@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Jones
Organizational Affiliation
VHAECH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward L Jones, MD
Phone
720-723-6462
Email
Edward.Jones1@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Activity Restrictions After Inguinal Hernia Repair

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