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.
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.
Canada1 site, 1 recruiting
- Recruiting
Shouldice hospital
Thornhill, Ontario, L3T 4A3
Christoph Paasch, 9058891125, cpaasch@shouldice.com
Marguerite Mainprize, 9058891125, mmainprize@shouldice.com
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:
- Explore the learning curve and factors affecting Shouldice repair.
- Compare operative times between a surgeon's early and later surgeries.
- Look at complications during the learning curve.
- Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.
- 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:
- To examine the learning curve and contributing variables of a Shouldice primary inguinal hernia repair
- To compare operative time between a surgeons first 300 Shouldice primary inguinal hernia repairs and their 900-1000
- To review learning curve and postoperative complications.
- To determine the training period at Shouldice Hospital and examine prior experience of surgeons.
- 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.
- The HerniaSurge Group (2018) International guidelines for groin hernia management. Hernia 22:1-165. https:// doi. org/ 10. 1007/s10029- 017- 1668-x
- Shouldice EB (2003) The Shouldice repair for groin hernias. Surg Clin N Am 83:1163-1187
- 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
- Shouldice EB (2010) Surgery illustrated-surgical atlas. the Shouldice natural tissue repair for inguinal hernia. BJUI 105:428-439
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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:
- Conditions
- Groin Hernia, Shouldice Procedure
- 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 group | Role | What they receive |
|---|---|---|
| Learning curve of Surgeon I | Not described Receives: Other: no intervention | |
| Learning curve of Surgeon II | Not described Receives: Other: no intervention | |
| Learning curve of Surgeon III | Not described Receives: Other: no intervention | |
| Learning curve of Surgeon IV | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted18 Mar 2024
- Study start11 Mar 2024
- Primary completion11 May 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Groin HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shouldice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Learning Curve of the Shouldice Procedure
- ClinicalTrials.gov ID
- NCT06314802
- Acronym / sponsor ID
- LCSR / LCSR
- Conditions
- Groin Hernia, Shouldice Procedure
- Keywords
- Inguinal hernia, Shouldice repair, Learning curve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Shouldice HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 11 May 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Explore the learning curve and factors affecting Shouldice repair.
- Compare operative times between a surgeon's early and later surgeries.
- Look at complications during the learning curve.
- Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.
- 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.
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:
- To examine the learning curve and contributing variables of a Shouldice primary inguinal hernia repair
- To compare operative time between a surgeons first 300 Shouldice primary inguinal hernia repairs and their 900-1000
- To review learning curve and postoperative complications.
- To determine the training period at Shouldice Hospital and examine prior experience of surgeons.
- 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.
- The HerniaSurge Group (2018) International guidelines for groin hernia management. Hernia 22:1-165. https:// doi. org/ 10. 1007/s10029- 017- 1668-x
- Shouldice EB (2003) The Shouldice repair for groin hernias. Surg Clin N Am 83:1163-1187
- 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
- Shouldice EB (2010) Surgery illustrated-surgical atlas. the Shouldice natural tissue repair for inguinal hernia. BJUI 105:428-439
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- A surgeon, who operated on at least 1000 primary inguinal hernias using the Shouldice technique
- Surgeon at the shouldice hospital
Key exclusion criteria (1 listed)
- A surgeon, who operated on less than 1000 primary inguinal hernias using the Shouldice technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention | Other | Learning curve of Surgeon I, Learning curve of Surgeon II, Learning curve of Surgeon III, Learning curve of Surgeon IV |
Primary outcome
Operating time I
Time frame: Operating time of shouldice primary hernia repair
Operating time of shouldice primary hernia repair after the first 300 cases
2 secondary outcomes
Operating time II
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.