Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069142
• Other study ID #: Pro00106451
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 9, 2023

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 9, 2023
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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

Locations

Country	Name	City	State
Canada	Fort Saskatchewan Community Hospital	Fort Saskatchewan	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Cabilan CJ, Hines S, Munday J. The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. JBI Database System Rev Implement Rep. 2015 Jan;13(1):146-87. doi: 10.11124/jbisrir-2015-1885. — View Citation

Ditmyer MM, Topp R, Pifer M. Prehabilitation in preparation for orthopaedic surgery. Orthop Nurs. 2002 Sep-Oct;21(5):43-51; quiz 52-4. doi: 10.1097/00006416-200209000-00008. — View Citation

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. — View Citation

HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12. — View Citation

Liang MK, Bernardi K, Holihan JL, Cherla DV, Escamilla R, Lew DF, Berger DH, Ko TC, Kao LS. Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial. Ann Surg. 2018 Oct;268(4):674-680. doi: 10.1097/SLA.0000000000002961. — View Citation

Lundberg M, Archer KR, Larsson C, Rydwik E. Prehabilitation: The Emperor's New Clothes or a New Arena for Physical Therapists? Phys Ther. 2019 Feb 1;99(2):127-130. doi: 10.1093/ptj/pzy133. No abstract available. — View Citation

Nienhuijs SW, Rosman C, Strobbe LJ, Wolff A, Bleichrodt RP. An overview of the features influencing pain after inguinal hernia repair. Int J Surg. 2008 Aug;6(4):351-6. doi: 10.1016/j.ijsu.2008.02.005. Epub 2008 Mar 4. — View Citation

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. — View Citation

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. — View Citation

Sobol-Kwapinska M, Babel P, Plotek W, Stelcer B. Psychological correlates of acute postsurgical pain: A systematic review and meta-analysis. Eur J Pain. 2016 Nov;20(10):1573-1586. doi: 10.1002/ejp.886. Epub 2016 May 2. — View Citation

Topp R, Ditmyer M, King K, Doherty K, Hornyak J 3rd. The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues. 2002 May;13(2):263-76. doi: 10.1097/00044067-200205000-00011. — View Citation

van Hanswijck de Jonge P, Lloyd A, Horsfall L, Tan R, O'Dwyer PJ. The measurement of chronic pain and health-related quality of life following inguinal hernia repair: a review of the literature. Hernia. 2008 Dec;12(6):561-9. doi: 10.1007/s10029-008-0412-y. Epub 2008 Aug 21. — View Citation

Yeo AE, Berney CR. Carolinas Comfort Scale for mesh repair of inguinal hernia. ANZ J Surg. 2012 Apr;82(4):285-6. doi: 10.1111/j.1445-2197.2012.06012.x. No abstract available. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.