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

Surgical Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877824
• Other study ID #: MEDU001
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: June 11, 2013
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Surgical Training

Intervention

Other:
• Fast-track training

Locations

Country	Name	City	State
Denmark	Centre of Medical Education	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital, Central Denmark Region, TRYG Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Operative time	The time in performing the surgical procedures are recorded.	Three years	Yes
Secondary	Satisfaction	The intervention group participants are asked for their experience and satisfaction with a fast-track program	Three years	No