Learning Curve of the Shouldice Procedure

NCT06314802 | Recruiting

• 1 other identifier: LCSR
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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

Conditions

Groin Hernia; Shouldice Procedure

Keywords

Inguinal hernia; Shouldice repair; Learning curve

Outcome Measures

Primary Outcomes (1)

• Operating time I

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

  Operating time of shouldice primary hernia repair

Secondary Outcomes (2)

• Operating time II

  Operating time of shouldice primary hernia repair after the 1000 cases

• Operating time III

  Operating time of shouldice primary hernia repair after the 1000 cases

Study Arms (4)

Learning curve of Surgeon I

Other: no intervention

Learning curve of Surgeon II

Other: no intervention

Learning curve of Surgeon III

Other: no intervention

Learning curve of Surgeon IV

Other: no intervention

Interventions

no intervention OTHER

No intervention

Learning curve of Surgeon I; Learning curve of Surgeon II; Learning curve of Surgeon III; Learning curve of Surgeon IV

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shouldice Hospital: lead

Study Sites (1)

Shouldice hospital

Thornhill, Ontario, L3T 4A3, Canada

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christoph Paasch

CONTACT

9058891125; cpaasch@shouldice.com

Marguerite Mainprize

CONTACT

9058891125; mmainprize@shouldice.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 11, 2024
• Primary Completion: May 11, 2024
• Study Completion: June 10, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CA (1)