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

NCT01877824 | Completed

• 1 other identifier: MEDU001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Training

Keywords

Surgery; Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Operative time

  Three years

• Satisfaction

  Three years

Study Arms (2)

Fast-track training

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Fast-track training OTHER

Fast-track training

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical doctors accepted for formal surgical training in Denmark in 2010-11.

You may not qualify if:

• Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures.
• Employed at a non-participating hospital.

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator
• Aalborg University Hospital: collaborator
• TRYG Foundation: collaborator

Study Sites (1)

Centre of Medical Education

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Carlsen CG, Lindorff-Larsen K, Funch-Jensen P, Lund L, Konge L, Charles P. Module based training improves and sustains surgical skills: a randomised controlled trial. Hernia. 2015 Oct;19(5):755-63. doi: 10.1007/s10029-015-1357-6. Epub 2015 Mar 3.

  PMID: 25731946 DERIVED

Study Officials

• Peder Charles, MD, DMSci

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 14, 2013
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

DK (1)