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

NCT ID: NCT01877824

Last Updated: 2013-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

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.

Detailed Description

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Conditions

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Surgical Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fast-track training

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.

Group Type EXPERIMENTAL

Fast-track training

Intervention Type OTHER

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fast-track training

Intervention Type OTHER

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Denmark Region

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

TRYG Foundation

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peder Charles, MD, DMSci

Role: STUDY_CHAIR

University of Aarhus

Locations

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Centre of Medical Education

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25731946 (View on PubMed)

Other Identifiers

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MEDU001

Identifier Type: -

Identifier Source: org_study_id

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