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Inguinal HerniaNCT07680777

Perioperative Rehab for Inguinal Hernia Repair

A study testing Rehabilitation in people with Inguinal Hernia, run by University of Alberta at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inguinal Hernia
What is being tested?
Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteCanada
Study dates
Sep 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Shologan contact

780-492-2690

asholo@ualberta.ca

Douglas Gross contact

780-492-2690

dgross@ualberta.ca

Canada1 site
  • University of Alberta

    Edmonton, Alberta

    Douglas Gross, 780-492-2690, dgross@ualberta.ca

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Inguinal Hernia
Being tested
Rehabilitation
Keywords
rehabilitation, prehabilitation
Medical subject headings
Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationOther

    Pre- and post-operative exercise and education.

Study groups in NCT07680777
Study groupRoleWhat they receive
Intervention GroupExperimental49 participants will be randomly selected to the intervention group. These participants will receive six weeks of pre-operative exercise and education, as well as six weeks of graduated post-operative exercise instruction, beginning at three weeks post-op with the surgeon's clearance.
Receives: Other: Rehabilitation
Control GroupNo intervention49 participants will be randomly selected to the control group. These participants will receive pre-operative education in the form of educational videos. They will not receive exercise instruction.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported pain due to hernia

    Pain as measured on the Pain Disability Index, scored 0-10, with 0 being no pain and 10 being the worst pain.

    Measured: From enrollment to 12 weeks post-op

Secondary outcomes (3)
  1. Hernia Recurrence

    Measured: At 12 weeks post-op

  2. Return to regular work/activity

    Measured: From enrollment to 12 weeks post-op

  3. Surgical experience

    Measured by feedback forms during final data collection at 12 weeks post-op.

    Measured: From enrollment to 12 weeks post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-arm parallel group randomized controlled trial
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680777
Sponsor's protocol ID
Pro00165111
Status last verified
Jun 2026
First submitted
19 Jun 2026
Last updated
2 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect personal health information IDP will not be shared.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 24768750
  • Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.

    PubMed 33054332
  • Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.

    PubMed 33536076
  • Alberta SPOR SUPPORT Unit (AbSPORU). Patient engagement in health research: a how-to guide for researchers. Edmonton (AB): Alberta SPOR SUPPORT Unit; 2018 (Version 8.0). Available from: https://absporu.ca/pei-how-to-guide.

  • Arhos EK, Poulose BK, Di Stasi S, Chaudhari AMW. Individuals with a ventral hernia who report moderate to high fear have worse functional performance than those with low fear. Hernia. 2024 Apr;28(2):643-649. doi: 10.1007/s10029-024-02979-0. Epub 2024 Feb 26.

    PubMed 38407674
  • Folland JP, Williams AG. The adaptations to strength training : morphological and neurological contributions to increased strength. Sports Med. 2007;37(2):145-68. doi: 10.2165/00007256-200737020-00004.

    PubMed 17241104
  • Forbes J, Fry N, Hwang H, Karimuddin AA. Timing of return to work after hernia repair: Recommendations based on a literature review. BC Medical Journal. 2012;54(7):341-5.

  • Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe K, Zwarenstein M; for the PRECIS 2 developers. PRECIS 2: PRagmatic Explanatory Continuum Indicator Summary. PRECIS 2 website. Available from: https://www.precis 2.org/. Accessed 28 Jul 2025.

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation in people with Inguinal Hernia, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Shologan (780-492-2690, asholo@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported pain due to hernia (time frame: From enrollment to 12 weeks post-op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07680777, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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