Perioperative Rehab for Inguinal Hernia Repair

Official title

Perioperative Rehabilitation for Individuals Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial

Overview

Despite how common inguinal hernia repair (IHR) surgery is, there is little research on how best to prepare people for this operation. Surgeons' advice to patients about exercise and physical activity are inconsistent and usually based on their clinical opinion. Some surgeons recommend exercise to help prepare for the operation while others say to rest. Research is needed to help know whether exercise is helpful before and after IHR surgery. This study will observe the effects of education and exercise before and immediately after IHR surgery. Half of the participants will be randomized to an education and exercise group and the other half to a non-exercise, care as usual group. Participant outcomes will be measured up to 3 months after their surgery. It is expected that participants in the education and exercise group will have: 1) less pain at follow-up, 2) better hernia-related outcomes, 3) quicker return to activity and work, and 4) improved overall experience surrounding IHR surgery. This project will help in developing clear guidelines for pre- and post-operation to better prepare patients for IHR surgery.

Detailed description

Inguinal hernia repair (IHR) surgery is one of the most common surgeries performed globally, with more than 20 million procedures annually. Despite the frequent occurrence of this condition and consequent surgical repair, patient outcomes for IHR need improvement; the rate of hernia recurrence following surgical repair is approximately 15% and an estimated 10-12% of patients undergoing this surgery have chronic post-surgical pain that lasts months or years. Poor surgical outcomes negatively affect individual patients who experience pain, activity limitation, and decreased quality of life. This also results in significant burden on employers and healthcare systems through decreased productivity, lost time at work, and an increased number of appointments.

Even though IHR is incredibly common, there is a lack of quality literature investigating the effects and safety of physical activity surrounding this condition. This results in recommendations given to patients that are variable, inconsistent, and largely based upon clinical opinion. Evidence from related surgical procedures suggests that preoperative exercise and education (prehabilitation), followed by postoperative rehabilitation may result in better outcomes following surgery. Though initially argued for orthopedic procedures and adopted to cardiovascular and pulmonary surgical procedures, the use of prehabilitation is spreading to other surgical subspecialties as well. One study observed that improved preoperative physical functioning as defined by a timed stair climbing task was associated with fewer postoperative complications in patients waiting to undergo major abdominal surgery and was a better predictor of perioperative complications than other risk factors such as chronic comorbidities, tobacco use, or alcohol abuse. A recent systematic review found that surgery type may not actually be an important modifier of prehabilitation efficacy, and that the benefits of prehabilitation span multiple surgical.

Perioperative rehabilitation for IHR is supported mainly by limited and indirect evidence. A study in 2018 was the first randomized controlled trial to examine the impact of a weight loss centered prehabilitation program on patients waiting to undergo ventral hernia repair and found improved hernia- and complication-free rates in the prehabilitation group following surgery, but also higher dropout and emergent repair rates in the prehabilitation group, raising safety concerns. A two-year follow-up study found no significant long-term differences in complications or sustained weight loss between standard care and prehabilitation groups. No studies currently combine prehabilitation and post-operative rehabilitation, or inform recovery time, post-surgical pain, and return to activity after inguinal hernia repair. Pain catastrophizing and fear of movement appear to be important predictors of postsurgical outcomes. Due to a lack of quality literature, recommendations given to patients that are based on clinical opinion that encourage limiting physical activity for extended periods of time can encourage unhelpful beliefs about pain, fear of movement and poor coping strategies. Research is needed to inform practice guidelines and return-to-activity recommendations.

This research team previously conducted a pilot study investigating the feasibility of a study investigating perioperative rehabilitation for IHR and discovered that a larger study is feasible in terms of recruitment, assessment, and protocol implementation. The investigators are now moving forward to a larger randomized controlled trial (RCT) with improvements and refinements to the protocol.

Interventions

• Other Rehabilitation
  Pre- and post-operative exercise and education.

Primary outcome measures

• Self-reported pain due to hernia [Time frame: From enrollment to 12 weeks post-op]

Secondary outcome measures (3)

• Hernia Recurrence [Time frame: At 12 weeks post-op]
• Return to regular work/activity [Time frame: From enrollment to 12 weeks post-op]
• Surgical experience [Time frame: From enrollment to 12 weeks post-op]

Eligibility criteria

Inclusion criteria

• scheduled to undergo first time elective inguinal hernia repair
• willing to participate in a 6-week exercise program before and after surgery
• internet access: ability to communicate via email and Zoom
• at least 18 years of age
• no medical contraindications to exercise

Exclusion criteria

• recurrent hernia
• poorly controlled comorbidities that may prevent safe participation in exercise
• use of opiates and/or opioids

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Canada · 1 center

• University of Alberta — Edmonton

Publications

• Canadian Society for Exercise Physiology (CSEP). 2017. Get Active Questionnaire[Online] Available from https://csep.ca/2021/01/20/pre-screening-for-physical-activity/.
• Poobalan AS, Bruce J, Smith WC, King PM, Krukowski ZH, Chambers WA. A review of chronic pain after inguinal herniorrhaphy. Clin J Pain. 2003 Jan-Feb;19(1):48-54. doi: 10.1097/00002508-200301000-00006. PMID 12514456
• Hansford HJ, Jones MD, Cashin AG, Ostelo RW, Chiarotto A, Williams SA, Sharma S, Rose JM, Devonshire JJ, Ferraro MC, Wewege MA, McAuley JH. The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study. J Orthop Sports Phys Ther. 2024 Jul;54(7):477-485. doi: 10.2519/jospt.2024.12279. Epub 2024 Apr 17. PMID 38630543
• Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413. PMID 30586070
• Heniford BT, Lincourt AE, Walters AL, Colavita PD, Belyansky I, Kercher KW, Sing RF, Augenstein VA. Carolinas Comfort Scale as a Measure of Hernia Repair Quality of Life: A Reappraisal Utilizing 3788 International Patients. Ann Surg. 2018 Jan;267(1):171-176. doi: 10.1097/SLA.0000000000002027. PMID 27655239
• Le Carre J, Luthi F, Burrus C, Konzelmann M, Vuistiner P, Leger B, Benaim C. Development and Validation of Short Forms of the Pain Catastrophizing Scale (F-PCS-5) and Tampa Scale for Kinesiophobia (F-TSK-6) in Musculoskeletal Chronic Pain Patients. J Pain Res. 2023 Jan 20;16:153-167. doi: 10.2147/JPR.S379337. eCollection 2023. PMID 36711115
• Melville MR, Lari MA, Brown N, Young T, Gray D. Quality of life assessment using the short form 12 questionnaire is as reliable and sensitive as the short form 36 in distinguishing symptom severity in myocardial infarction survivors. Heart. 2003 Dec;89(12):1445-6. doi: 10.1136/heart.89.12.1445. No abstract available. PMID 14617561
• Crighton AH, Wygant DB, Applegate KC, Umlauf RL, Granacher RP. Can brief measures effectively screen for pain and somatic malingering? Examination of the Modified Somatic Perception Questionnaire and Pain Disability Index. Spine J. 2014 Sep 1;14(9):2042-50. doi: 10.1016/j.spinee.2014.04.012. Epub 2014 Apr 24. PMID 24768750

Identifiers

NCT: NCT07680777 · Pro00165111

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗