Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery

Study Overview
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Brief Summary
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Inguinal hernia repair is one of the most common surgeries, with more than 20 million performed globally each year. It is estimated that approximately 15% of patients undergoing inguinal hernia repair will experience persistent post-surgical pain that could last months to years. Evidence from related procedures indicates that better surgical preparation through pre-operative exercise and education (i.e. Prehabilitation) followed by ongoing post-surgical rehabilitation leads to more rapid recovery, return to activities and lower likelihood of persistent post-surgical pain. The investigators will determine the feasibility of a peri-operative rehabilitation program (pre- and post-surgery) and our study protocol for patients undergoing inguinal hernia repair surgery. The investigators hypothesize that: 1) our peri-operative intervention will be feasible and safe to undertake within a clinical setting; 2) adequate numbers will be enrolled to justify a larger trial; and that 3) our outcome measurement protocol will provide meaningful information with high response rate and low attrition after 3 months.

Detailed Description
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Inguinal hernia repair is one of the most common surgeries performed globally, with more than 20 million performed each year. Not only does this huge number of surgeries have a substantial direct economic burden on healthcare systems, there is also indirect impact from time off work and decreased productivity due ongoing post-surgical pain requiring extended time spent on modified duties. It is estimated that approximately 15% of patients undergoing inguinal hernia repair will experience persistent post-surgical pain that could last months to years. Furthermore, current clinical guidelines for return to work and activity after inguinal hernia repair are inconsistently informed by evidence, highly variable, and outdated. Forbes et al (2012) found that the average patient undergoing inguinal hernia repair experiences more than 40 days of short-term disability despite indications that earlier return to activity is safe (i.e. will not lead to repair failure) and likely beneficial for reducing chronic pain and disability. Evidence from related procedures indicates that better surgical preparation through pre-operative exercise and education (i.e. Prehabilitation) followed by ongoing post-surgical rehabilitation leads to more rapid recovery, return to activities and lower likelihood of persistent post-surgical pain. Prehabilitation was first described in the 1940's when the British Army developed a prehabilitation program as part of an experiment to increase the quality of recruits. The concept of prehabilitation gained traction within the medical community when Topp et. al. and Ditmyer et. al. promoted a theoretical model of prehabilitation, positing that patients who participate in presurgical exercise with the goal of improving functional capacity may experience more rapid postoperative recovery than patients who remain physically inactive through the preoperative period. Prehab has also been shown to increase self-efficacy, a moderator of pain catastrophizing and fear avoidance beliefs, that are important factors linked to the pain experience of those with persistent pain. The investigators propose that this theoretical model can be extrapolated to inguinal hernia repair and theorize that prehabilitation will increase patients' preoperative self-efficacy, allowing them to more rapidly regain abilities, subsequently shortening duration of modified duties and decreasing likelihood of persistent post-surgical pain. Little information is available regarding the use of prehabilitation in the context of inguinal hernia repair. There have been numerous studies looking at prehabilitation in orthopedics, cardiovascular surgery, and prior to major abdominal surgeries, but limited studies for inguinal hernia repair. A randomized control study by Liang et. al. examined the impact of prehabilitation on ventral hernia recurrence and post-operative complications. They concluded that patients undergoing prehabilitation have a higher likelihood of being hernia-free and complication-free 30 days postoperatively. Notably, this study is limited in that only obese patients were included, and outcomes only included recurrence and complications. No studies were located examining the impact of prehabilitation on recovery time, post-surgical pain, and return to activity after inguinal hernia repair. However psychosocial factors such as pain catastrophizing appear to be important predictors. Typical practice guidelines often recommend limiting activity for at least 3 months to avoid re-rupture. However, these guidelines are based on expert opinion due to a lack of quality research and can pose a risk in building unhelpful beliefs about pain, fear of movement and poor coping strategies. Research is needed to inform practice guidelines and return-to-activity recommendations.

Official Title
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A Study Evaluating the Feasibility of a Peri-Operative Rehabilitation Program for Inguinal Hernia Repair Surgery to Reduce Risk of Post-Surgical Pain

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo first-time inguinal hernia repair surgery after a physical examination identified signs and symptoms consistent with inguinal hernia (direct or indirect hernia) Willingness to participate in a targeted peri-operative exercise program 18+ years of age No medical contraindications to participation in exercise Employed full-time and required to lift at least 10kg for work Exclusion Criteria: Previous inguinal hernia Body Mass Index >35 since morbidly obese patients experience more surgical complications Specific contra-indications that will be screened for include associated medical conditions that preclude exercise, this includes uncontrolled medical conditions including diabetes, hypertension, vertigo, congestive heart failure, chronic obstructive pulmonary disease, intra-abdominal ascites, or pre-existing malnutrition. We will also screen for use or narcotics, bone and joint conditions of the spine or extremities, or history of other abdominal surgeries.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot Parallel-Group Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>15 participants will be randomly selected to the intervention group. These individuals will receive six weeks of pre-operative exercise instruction and education, as well as six weeks of graduated post-operative exercise instruction, beginning at three weeks post-op with the surgeons clearance. | Other: Rehabilitation<br>* Pre- and post-operative exercise and education.<br>|
| No Intervention: Control group<br>15 participants will be randomly selected to the control group. This group will receive pre-operative education in the form of videos regarding the procedure and pain. They will not receive exercise instruction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Scale | Post-surgical pain intensity ratings will be measured on a 0-100mm Visual Analogue Scale, a valid measure of pain intensity. | 3 Months after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carolinas Comfort Scale (CCS) | Post-surgical pain quality will be measured using the Carolinas Comfort Scale (CCS), a questionnaire for evaluating pain and sensations experienced by patients after inguinal hernia operations. | 3 Months after the operation | 
| Change in scores on the Short-Form Functional Capacity Evaluation | The Short-Form Functional Capacity Evaluation is a performance-based test of work function. In this test, patients are tested on 5 key activities of work performance (lifting, standing, trunk rotation, crouching, forward trunk flexion). Performance on each scale is compared to required job demands and the number of failed items is summed (0 to 5 failures). Short-Form Functional Capacity Evaluation is a valid indicator of work ability that has been found predictive of future work ability. | Changes between baseline to three months after the operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, prehabilitation