Recruiting

Shouldice Procedure

Sponsor:

Shouldice Hospital

Code:

NCT06314802

Conditions

Groin Hernia

Shouldice Procedure

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

no intervention

Study Details

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. 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.

Conditions

Groin Hernia

Shouldice Procedure

Study ID

NCT06314802

Start date

Mar 11, 2024

Status verified date

Mar, 2024

Completion date

Jun 10, 2024

Anticipated

Primary completion date

May 11, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Arms

Learning curve of Surgeon I

Learning curve of Surgeon II

Learning curve of Surgeon III

Learning curve of Surgeon IV

Interventions

no intervention

No intervention

Primary outcome measure

  • Operating time I [ Time Frame: Operating time of shouldice primary hernia repair ]

Central Contacts and Locations

Central contacts

Locations

Shouldice hospital

Recruiting

Thornhill, Ontario, Canada, L3T 4A3

Contacts

More Information

Sponsor

Shouldice Hospital

Last update posted

Mar 18, 2024

Last verified

Mar, 2024

Keywords

  • Inguinal hernia
  • Shouldice repair
  • Learning curve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shouldice Hospital on 2024-03-18.