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Groin HerniaLCSRNCT06314802

Learning Curve of the Shouldice Procedure

An observational study of Groin Hernia and Shouldice Procedure, run by Shouldice Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Read more about this study

Who is it for?
Ages 16 to 99 years
Conditions the study is for
Groin Hernia, Shouldice Procedure
How many people
1,600 participants
Where
1 siteCanada
Study dates
11 Mar 2024to 10 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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 16 to 99 years
  • All sexes
  • Child, Adult, Older adult

Study population: Study Population: The study population will include male and female patients aged 16-90 years of age, standard age of patients accepted for surgery at Shouldice Hospital, who had a Shouldice repair of a primary inguinal hernia at Shouldice Hospital, all nationalities and races, capable of speaking and reading English, in good general health, and there is no geographic location constraint. Patients will be excluded if they underwent a mesh repair, repair of a scrotal hernia, non-Shouldice or modified Shouldice tissue repair, a hernia that was not an inguinal type, recurrent hernias, repairs with bowel resection, and/or and surgery was deemed an emergency.

Who may be able to join

  • A surgeon, who operated on at least 1000 primary inguinal hernias using the Shouldice technique
  • Surgeon at the shouldice hospital

Who cannot join

  • A surgeon, who operated on less than 1000 primary inguinal hernias using the Shouldice technique

Trial locations and contacts

1 site in 1 country.

Christoph Paasch contact

9058891125

cpaasch@shouldice.com

Marguerite Mainprize contact

9058891125

mmainprize@shouldice.com

Canada1 site, 1 recruiting
  • Shouldice hospital

    Thornhill, Ontario, L3T 4A3

    Christoph Paasch, 9058891125, cpaasch@shouldice.com

    Marguerite Mainprize, 9058891125, mmainprize@shouldice.com

    Recruiting

Other trials in Canada

About this study

Official title: Evaluation of the Learning Curve of the Shouldice Procedure

Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Many surgeons are trained more in mesh repairs like the Lichtenstein technique, rather than nonmesh repairs like Shouldice.

Understanding a surgeon's learning curve-how many surgeries they need to do to become proficient-is crucial. Yet, there's not much research on this for the Shouldice repair. This project aims to fill that gap and improve surgeon education.

Read more

The study's goal is to find out how the learning curve affects Shouldice repair for primary inguinal hernias. They'll look at how operative time changes over a surgeon's first 300 repairs compared to their 900-1000th. They'll also check for complications and recurrence rates.

The study objectives are:

  1. Explore the learning curve and factors affecting Shouldice repair.
  2. Compare operative times between a surgeon's early and later surgeries.
  3. Look at complications during the learning curve.
  4. Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.
  5. Review recurrence rates between the first 300 and 900-1000 surgeries.

This research aims to give surgeons and the hernia community valuable insights into improving surgical techniques and patient outcomes.

Read the detailed description

Hernia repair is one of the most commonly performed general surgeries [1]. Shouldice repair for primary inguinal hernias is a well-known and documented surgical technique [2,3] and considered to be the gold standard nonmesh hernia repair [1]. The results in the literature for a Shouldice primary inguinal hernia repair vary greatly [2,4,5], and may be due to a lack of accuracy in performing the repair [5,6] and/or lack of surgical volume and experience [7-9]. An added contributing factor could be that nonmesh repairs are not principally taught to many residents, instead the primary method taught is the Lichtenstein repair [10], which leaves out early training of nonmesh repairs, like the Shouldice Repair.

Learning curve can evaluate surgeons' performance and status (trainee or expert), which is done by determining the minimum number of procedures it takes to reach similar outcomes as known expert surgeons [10]. However, there is limited research that describes learning curve and the minimum number of hernia techniques to perform before being considered proficient [1,11]. Some research has performed analysis, which focused on operating times, to determine the learning curve for the Lichtenstein [10] and similar learning and proficiency research on TAPP [12] hernia repair procedures.

The rationale for this project is to supply valuable information to general surgeon trainees and experts, as well as the broader hernia community. There is little to no research done on the learning curve of the Shouldice repair for primary inguinal hernias and the importance of offering and learning nonmesh hernia repairs are associated with the risk of complications after mesh use, as well as treating patients who would prefer a nonmesh repairs [1]. Therefore, the significance of this project is to improve the understanding and knowledge regarding Shouldice Repair and increase surgeon education.

The purpose of this study is to determine the learning curve of a Shouldice repair for primary inguinal hernias. The primary endpoint is differences in operative length while secondarily evaluating recurrence rate and other complications.

Study Objectives:

  1. To examine the learning curve and contributing variables of a Shouldice primary inguinal hernia repair
  2. To compare operative time between a surgeons first 300 Shouldice primary inguinal hernia repairs and their 900-1000
  3. To review learning curve and postoperative complications.
  4. To determine the training period at Shouldice Hospital and examine prior experience of surgeons.
  5. To review mean time to recurrence during a surgeon's first 300 Shouldice primary inguinal hernia repairs and their 900-1000

The proposed project is a pilot study consisting of a retrospective review to collect information on the learning curve of a Shouldice primary inguinal hernia repair, done at Shouldice Hospital. The study will consist of surgeons who worked at Shouldice Hospital in 2023, were hired within the past 10 years, and performed a minimum of 1000 primary inguinal hernia repairs. We estimate 4 surgeons to be included. The study will compare surgeons' first 300 Shouldice primary inguinal hernia repairs to their 900-1000. The parameters of 300 and 1000 hernia repairs were chosen based on previous publications [1,3], which used those benchmarks to indicate proficiency and expertise of the repair. We will analyze the learning curve by using operating time which has also been done for Lichtenstein [10] and similar research in TAPP [12] hernia repairs.

  1. The HerniaSurge Group (2018) International guidelines for groin hernia management. Hernia 22:1-165. https:// doi. org/ 10. 1007/s10029- 017- 1668-x
  2. Shouldice EB (2003) The Shouldice repair for groin hernias. Surg Clin N Am 83:1163-1187
  3. Mainprize, M., Spencer Netto, F.A.C., Degani, C. et al. The Shouldice Method: an expert's consensus. Hernia 27, 147-156 (2023). https://doi.org/10.1007/s10029-022-02658-y
  4. Shouldice EB (2010) Surgery illustrated-surgical atlas. the Shouldice natural tissue repair for inguinal hernia. BJUI 105:428-439
  5. Lorenz R, Arlt G, Fortelny R, Gorjanc J, Koch A, Morrison J,Oprea V, Campanelli G (2020) Shouldice standard 2020: review of the current literature an results of an international consensus meeting. Hernia 25(5):1199-1207
  6. Malik A, Bell CM, Stukel TA, Urbach DR (2016) Recurrence of inguinal hernias repaired in a large hernia surgical speciality hospital and general hospitals in Ontario. Can J Surg 59(1):19-25
  7. Andresen K, Friis-Andersen H, Rosenberg J (2016) Laparoscopic repair of primary inguinal hernia performed in public hospitals or low-volume centers have increased risk of reoperation for recurrence. Surg Innov 23:142-147
  8. Kockerling F, Bitter R, Kraft B, Hukauf M, Kuthe A, Schug-Pass C (2017) Does surgeons volume matter in the outcome of endoscopic inguinal hernia repair? Surg Endosc 31:573-585
  9. Nordin P, van der Linden W (2008) Volume of procedures and risk of recurrence after repair of gorin hernias: national register study. Br Med J 336:934-937
  10. Merola G, Cavallaro G, Iorio O, Frascio M, Pontecorvi E, Corcione F, Andreuccetti J, Pignata G, Stabilini C, and Bracale U. Learning curve in open inguinal hernia repair: a quality improvement multicentre study about Lichtenstein technique. Hernia (2020) 24:651-659. https://doi.org/10.1007/s10029-019-02064-x
  11. Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia (2009) 13:343-403.
  12. Brucchi F, Ferraina F, Masci E, Ferrara D, Bottero L, and Faillace GG. Standardization and learning curve in laparoscopic hernia repair: experience of a high-volume center. BMC Surgery (2023) 23:212. https://doi.org/10.1186/s12893-023-02119-y

Supplemental Material:

Being tested
no intervention
Keywords
Inguinal hernia, Shouldice repair, Learning curve
Medical subject headings
Hernia, Inguinal

What participants receive

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

  • no interventionOther

    No intervention

Study groups in NCT06314802
Study groupRoleWhat they receive
Learning curve of Surgeon INot described
Receives: Other: no intervention
Learning curve of Surgeon IINot described
Receives: Other: no intervention
Learning curve of Surgeon IIINot described
Receives: Other: no intervention
Learning curve of Surgeon IVNot described
Receives: Other: no intervention

What is being measured

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

  1. Operating time I

    Operating time of shouldice primary hernia repair after the first 300 cases

    Measured: Operating time of shouldice primary hernia repair

Secondary outcomes (2)
  1. Operating time II

    Operating time of shouldice primary hernia repair after the 1000 cases

    Measured: Operating time of shouldice primary hernia repair after the 1000 cases

  2. Operating time III

    Interindividual comparison of operating time between surgeon I, II, III and IV

    Measured: Operating time of shouldice primary hernia repair after the 1000 cases

Timeline

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

  1. First posted18 Mar 2024
  2. Study start11 Mar 2024
  3. Primary completion11 May 2024 (estimated)
  4. Study completion10 Jun 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314802
Sponsor's protocol ID
LCSR
Acronym
LCSR
Status last verified
Mar 2024
First submitted
11 Mar 2024
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Groin Hernia and Shouldice Procedure, run by Shouldice Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. 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?

Results are not available in the source record.

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

Contact Christoph Paasch (9058891125, cpaasch@shouldice.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operating time I (time frame: Operating time of shouldice primary hernia repair). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Mar 2024.

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