Peri-Operative Rehab Program for Inguinal Hernia Repair Surgery

NCT05069142 | Completed

• 1 other identifier: Pro00106451
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

rehabilitation; prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Carolinas Comfort Scale (CCS)

  3 Months after the operation

• Change in scores on the Short-Form Functional Capacity Evaluation

  Changes between baseline to three months after the operation.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Rehabilitation OTHER

Pre- and post-operative exercise and education.

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + years of age
• No medical contraindications to participation in exercise
• Employed full-time and required to lift at least 10kg for work

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Fort Saskatchewan Community Hospital

Ft Saskatchewan, Alberta, Canada

Location

Related Publications (14)

• 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.

  PMID: 29330835 BACKGROUND

• 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.

  PMID: 18716856 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26447015 BACKGROUND

• 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.

  PMID: 30508203 BACKGROUND

• 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.

  PMID: 12011598 BACKGROUND

• 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.

  PMID: 12432699 BACKGROUND

• 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.

  PMID: 30048306 BACKGROUND

• 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.

  PMID: 18450528 BACKGROUND

• 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.

  PMID: 27136510 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22510195 BACKGROUND

• 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 BACKGROUND

• Shologan A, Farooq O, Bostick G, Macedo L, Durand-Moreau Q, Peters MR, Gross DP. A pilot randomized controlled trial examining the feasibility of perioperative rehabilitation for inguinal hernia repair surgery. PLoS One. 2025 May 22;20(5):e0324907. doi: 10.1371/journal.pone.0324907. eCollection 2025.

  PMID: 40403095 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blind to group status
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Parallel-Group Randomized Controlled Trial

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 6, 2021
• Study Start: January 1, 2022
• Primary Completion: October 12, 2022
• Study Completion: June 9, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)