Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Inguinal Hernia focused on measuring rehabilitation, prehabilitation
Eligibility Criteria
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.
Sites / Locations
- Fort Saskatchewan Community Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05069142
First Posted
September 22, 2021
Last Updated
October 19, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT05069142
Brief Title
Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
June 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
rehabilitation, prehabilitation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Parallel-Group Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Assessors are blind to group status
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Pre- and post-operative exercise and education.
Primary Outcome Measure Information:
Title
Visual Analogue Pain Scale
Description
Post-surgical pain intensity ratings will be measured on a 0-100mm Visual Analogue Scale, a valid measure of pain intensity.
Time Frame
3 Months after the operation
Secondary Outcome Measure Information:
Title
Carolinas Comfort Scale (CCS)
Description
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.
Time Frame
3 Months after the operation
Title
Change in scores on the Short-Form Functional Capacity Evaluation
Description
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.
Time Frame
Changes between baseline to three months after the operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fort Saskatchewan Community Hospital
City
Fort Saskatchewan
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Since this is a pilot study we have no plans to share IPD with other researchers
Citations:
PubMed Identifier
29330835
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.
Results Reference
background
PubMed Identifier
18716856
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.
Results Reference
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PubMed Identifier
12514456
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.
Results Reference
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PubMed Identifier
26447015
Citation
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.
Results Reference
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PubMed Identifier
30508203
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.
Results Reference
background
PubMed Identifier
12011598
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.
Results Reference
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PubMed Identifier
12432699
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.
Results Reference
background
PubMed Identifier
30048306
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.
Results Reference
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PubMed Identifier
18450528
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.
Results Reference
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PubMed Identifier
27136510
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery
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