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NCT01085500 · ClinicalTrials.gov registry record · NA

Mastery Learning Inguinal Hernia Repair

A NA study, sponsored by Mayo Clinic.

Completed
Registry status
NA
Development phase
50
Enrollment target

NCT01085500: Completed NA study, sponsored by Mayo Clinic.

NCT01085500 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01085500, a NA study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target

Study Summary

Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate laparoscopic skills. For economic, ethical, and legal considerations, the operating room may no longer be the ideal environment for teaching these basic technical skills. There appears to be a role for simulation in response to this need. The transfer of laparoscopic skills learned in a simulated environment to the operating room has showed mixed results. Overall, it seems that surgical skills training outside the operating room is beneficial, but the best method(s) of designing, implementing and evaluating such skills curriculums have yet to be identified. The laparoscopic totally extraperitoneal (TEP) inguinal hernia repair is an example of a procedure that is associated with a steep learning curve and requires mastery of basic laparoscopic skills. In addition, an increased recurrence and complication rates in the early learning curve of this procedure, underscores the importance of adequate training. The current practice of teaching the TEP repair in the operating room under an apprenticeship-based model is associated with increased operative time and costs. We propose that the training of surgical trainees outside the operating room with a structured, mastery oriented simulation-based curriculum will help reduce the learning curve of the TEP repair, improve operative performance, and decrease operative time and costs.

Primary Outcome

Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time\_corrected = time\_raw + (1-participation) x time\_raw.

Interventions

  • BEHAVIORAL Mastery Learning TEP Curriculum
  • PROCEDURE Current Practice

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2010-02
Est. Completion 2011-05
Phase NA
Mayo Clinic

2,844 total trials

What the finished NCT01085500 record still lists

NCT01085500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Mastery Learning TEP Curriculum is the first listed.

NCT01085500 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01085500 about?

NCT01085500 is a clinical study titled "Mastery Learning Inguinal Hernia Repair". Abstract: Minimally invasive techniques are now ubiquitous in the management of surgical disease. Competence in laparoscopy requires specialized training and practice. With the decrease of resident work hours, training programs need to explore and adopt efficient strategies to teach and evaluate lap...

What is the current status of trial NCT01085500?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2010-02. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01085500?

The interventions under investigation include: Mastery Learning TEP Curriculum (BEHAVIORAL), Current Practice (PROCEDURE).

Who is sponsoring clinical trial NCT01085500?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01085500's enrollment target sits among peer trials

50 1279th of 2000 higher than 622 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01085500, the US trial registry maintained by the National Library of Medicine. NCT01085500 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.