Study of Fast-track Surgery in Hernia Repair and Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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All Danish trainees in surgery in a two-year period asked for participation when enrolled in the formal five-year training program for specialty in surgery. The participants are randomized for either educational intervention or control (without intervention). The intervention group receive a skills-lab course in hernia repair followed by an opportunity to perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will be video recorded three times during the intervention and as follow-up at end of the first year of training. After termination of the hernia training program a similar program for laparoscopic cholecystectomies are made. Each participant receive both intervention. The control group are video recorded at start of their first year and at end. All videos are blindly assessed with a validated rating scale of operative performance. The purpose is to assess if a fast-track program improves technical skills and if a change is sustained. Furthermore we want to compare outcome in similar training programs in open and laparoscopic skills.

Official Title
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Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.

Conditions
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Surgical Training

Intervention / Treatment
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* Other: Fast-track training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical doctors accepted for formal surgical training in Denmark in 2010-11. Exclusion Criteria: Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures. Employed at a non-participating hospital.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast-track training<br>A skills-lap course (1 day) followed by opportunity to perform 20 planned surgical procedures of each type (open groin hernia repair and laparoscopic cholecystectomy) under supervision and within 4-8 weeks. Videorecording at start, mid and end and at follow-up before ending first year of training. | Other: Fast-track training<br> <br> |
| No Intervention: Control<br>Follows the existing training program without intervention. Video recording of the trainee performing a open groin hernia repair and a laparoscopic cholecystectomy procedure at start end end of first training year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical skills in performed surgical procedures | Blinded video recordings of the trainees' performances are rated with a validated rating scale of technical skills. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The time in performing the surgical procedures are recorded. | Three years | 
| Satisfaction | The intervention group participants are asked for their experience and satisfaction with a fast-track program | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Training