Surgical TrainingNCT01877824
Study of Fast-track Surgery in Hernia Repair and Laparoscopic Cholecystectomy
A study testing Fast-track training in people with Surgical Training, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Surgical Training
- What is being tested?
- Fast-track training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical doctors accepted for formal surgical training in Denmark in 2010-11.
Who cannot join
- Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures.
- Employed at a non-participating hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.
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
- Being tested
- Fast-track training
- Keywords
- Surgery, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-track trainingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical skills in performed surgical procedures
Blinded video recordings of the trainees' performances are rated with a validated rating scale of technical skills.
Measured: Three years
Secondary outcomes (2)
Operative time
The time in performing the surgical procedures are recorded.
Measured: Three years
Satisfaction
The intervention group participants are asked for their experience and satisfaction with a fast-track program
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical TrainingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, Aalborg University Hospital, TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Peder Charles, MD, DMSci, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877824
- Sponsor's protocol ID
- MEDU001
- Status last verified
- Jun 2013
- First submitted
- 27 May 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25731946
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.
- ClinicalTrials.gov ID
- NCT01877824
- Acronym / sponsor ID
- MEDU001
- Conditions
- Surgical Training
- Keywords
- Surgery, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region, Aalborg University Hospital, TRYG Foundation
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-track training | Experimental | Other: Fast-track trainingA 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. |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical doctors accepted for formal surgical training in Denmark in 2010-11.
Key exclusion criteria (2 listed)
- Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures.
- Employed at a non-participating hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-track training | Other | Fast-track training |
Primary outcome
Technical skills in performed surgical procedures
Time frame: Three years
Blinded video recordings of the trainees' performances are rated with a validated rating scale of technical skills.
2 secondary outcomes
Operative time
Time frame: Three years
Satisfaction
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Derived from this study: PubMed 25731946Carlsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peder Charles, MD, DMSci study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-track training in people with Surgical Training, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical skills in performed surgical procedures (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.