Learning Curve of the Shouldice Procedure (LCSR)

March 11, 2024 updated by: Shouldice Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Learning curve of Surgeon I
Other: no intervention
No intervention
Learning curve of Surgeon II
Other: no intervention
No intervention
Learning curve of Surgeon III
Other: no intervention
No intervention
Learning curve of Surgeon IV
Other: no intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operating time I
Time Frame: Operating time of shouldice primary hernia repair
Operating time of shouldice primary hernia repair after the first 300 cases
Operating time of shouldice primary hernia repair

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operating time II
Time Frame: Operating time of shouldice primary hernia repair after the 1000 cases
Operating time of shouldice primary hernia repair after the 1000 cases
Operating time of shouldice primary hernia repair after the 1000 cases
Operating time III
Time Frame: Operating time of shouldice primary hernia repair after the 1000 cases
Interindividual comparison of operating time between surgeon I, II, III and IV
Operating time of shouldice primary hernia repair after the 1000 cases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shouldice Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCSR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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