Performance of Inappropriate OperationNCT01405443
Simulator Training for Gastrointestinal Endoscopy
An observational study of Performance of Inappropriate Operation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Performance of Inappropriate Operation
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy?
This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.
Read the detailed description
Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.
- Conditions
- Performance of Inappropriate Operation
- Keywords
- Simulator training, Flexible endoscopy, Gastrointestinal endoscopy, Colonoscopy, Training, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Basic training | Theory lecture esophagogastroduodenoscopy (EGD). One hour simulator training for EGD. 30 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. One hour simulator training for Colonoscopy. 30 minutes supervised training. Supervised endoscopy. Group will be followed up for 2 weeks training time. | |
| Intermediate training | Theory lecture EGD. Three hours simulator training for EGD. 60 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Three hours simulator training for Colonoscopy. 60 minutes supervised training. Supervised endoscopy. Group will be followed up for 4 weeks training time. | |
| Extended training | Theory lecture EGD. Five hours simulator training for EGD. 90 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Five hours simulator training for Colonoscopy. 90 minutes supervised training. Supervised endoscopy. Group will be followed up for 6 weeks training time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Measured: Score is evaluated after one week training
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group three
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Measured: Score is evaluated after three weeks of training
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group two
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Measured: Score is evaluated after two weeks of training
Secondary outcomes (1)
Simulator score
Scores as evaluated by the Simbionix simulator software
Measured: Score is evaluated after the training period (at one week for group 1, at 2 weeks for group 2, and at three weeks for group 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: invalid data
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 Performance of Inappropriate OperationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405443
- Sponsor's protocol ID
- UKE Hamburg Endoscopy PV3656
- Status last verified
- Jun 2019
- First submitted
- 15 Apr 2011
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sabrie N, Khan R, Plahouras J, Johnston BC, Scaffidi MA, Grover SC, Walsh CM. Virtual reality simulation training for health professions trainees in gastrointestinal endoscopy. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD008237. doi: 10.1002/14651858.CD008237.pub4.
PubMed 40919710
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulator Training for Gastrointestinal Endoscopy - How Much Simulator Training is Required to Acquire Proficiency in Gastrointestinal Endoscopy?
- ClinicalTrials.gov ID
- NCT01405443
- Acronym / sponsor ID
- UKE Hamburg Endoscopy PV3656
- Conditions
- Performance of Inappropriate Operation
- Keywords
- Simulator training, Flexible endoscopy, Gastrointestinal endoscopy, Colonoscopy, Training, Performance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: invalid data
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 2011 (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.
This is a randomized controlled trial evaluating three training intervals using an endoscopy simulator for novices and comparing performance after training.
Detailed description
Randomized controlled trial evaluating different training intervals on an endoscopy simulator and comparing performance using a validated score (Global assessment of Gastrointestinal Endoscopic Skills). Physicians participating in the study are novices with no previous experience in flexible endoscopy. Subjects are randomized into three different training arms. Proficiency scores will be evaluated by a supervising physician blinded to group allocation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic training | – | –Theory lecture esophagogastroduodenoscopy (EGD). One hour simulator training for EGD. 30 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. One hour simulator training for Colonoscopy. 30 minutes supervised training. Supervised endoscopy. Group will be followed up for 2 weeks training time. |
| Intermediate training | – | –Theory lecture EGD. Three hours simulator training for EGD. 60 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Three hours simulator training for Colonoscopy. 60 minutes supervised training. Supervised endoscopy. Group will be followed up for 4 weeks training time. |
| Extended training | – | –Theory lecture EGD. Five hours simulator training for EGD. 90 minutes supervised training. Supervised endoscopy. Theory lecture Colonoscopy. Five hours simulator training for Colonoscopy. 90 minutes supervised training. Supervised endoscopy. Group will be followed up for 6 weeks training time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians in residency or fellowship programs requiring training in flexible endoscopy (gastroenterology, internal medicine, surgery) with no experience in flexible endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one
Time frame: Score is evaluated after one week training
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group three
Time frame: Score is evaluated after three weeks of training
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group two
Time frame: Score is evaluated after two weeks of training
Score is a validated measuring tool based on intubation, scope navigation, ability to keep a clear endoscopic visualization and instrumentation.
1 secondary outcome
Simulator score
Time frame: Score is evaluated after the training period (at one week for group 1, at 2 weeks for group 2, and at three weeks for group 3)
Results and safety
The study was stopped early (reason given: invalid data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 40919710Sabrie N, Khan R, Plahouras J, Johnston BC, Scaffidi MA, Grover SC, Walsh CM. Virtual reality simulation training for health professions trainees in gastrointestinal endoscopy. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD008237. doi: 10.1002/14651858.CD008237.pub4.
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.
Thomas Rösch, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Performance of Inappropriate Operation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 6 Jun 2019. 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 Germany. 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 was stopped early (reason given: invalid data). Results are not available in the source record.
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?
Validated proficiency score (GAGES "Global assessment for Gastrointestinal Endoscopy") for group one (time frame: Score is evaluated after one week training). The study lists 3 primary outcomes in all. 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 NCT01405443, 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 6 Jun 2019.