Gastrointestinal Endoscopy TrainingNCT02735655
Global State of Digestive Endoscopy Training Survey
An observational study of Gastrointestinal Endoscopy Training, run by Al-Azhar University at 13 sites in 12 countries.
Trial summary
This is a 10 minutes web based survey aims at exploring the current, global state of digestive endoscopy training among physicians to identify what are the unmet needs and how to improve it. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastrointestinal Endoscopy Training
- What is being tested?
- Physician's opinion
- How many people
- 1,000 participants
- Where
- 13 sitesin 12 countries
- Study dates
- Apr 2016to Mar 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians practicing gastrointestinal endoscopy
Who may be able to join
- Physicians practicing gastrointestinal endoscopy from all over the world
Who cannot join
- Any other persons whom are not physicians or physicians not practicing gastrointestinal endoscopy
Trial locations and contacts
13 sites in 12 countries.
13 sites in 12 countries
Egypt2 sites, 2 recruiting
- Recruiting
Al-Azhar Univerisity
Cairo, Cairo Governorate, 11651
Mohamed Alboraie, MD, 00201222717078, m.alboraie@gmail.com
Mohamed Alboraie, MD, MRCP(UK)
- Recruiting
Faculty of Medicine, Zagazig University
Zagazig, Sharqia Province, 44519
Mohamed Emara, M.D., 00201002724482, emara_20007@yahoo.com
Mohamed Emara, M.D.
United States1 site, 1 recruiting
- Recruiting
Kings County Hospital Center, Brooklyn, NY, USA
Albertson, New York, 11507
Shahzad Iqbal, MD, 718-245-3774, siqbal50@gmail.com
Shahzad Iqbal, MD
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital, Gastroenterology Department, Université Libre de Bruxelles (ULB)
Brussels, 1070
Mona Hamman, MD, +32.2.555.47.64, Mona.Hammam@erasme.ulb.ac.be
Mohammed Amrani, +32.2.555.83.82, Mohammed.Amrani@erasme.ulb.ac.be
Brazil1 site, 1 recruiting
- Recruiting
São Lucas Academic Hospital - Gastroclínica Cascavel
Cascavel, 85812-090
Ivan Orso, MD, PhD, + 55 45 21001-7700, ivan@gastro.com.br
Ivan Orso, MD, PhD
Chile1 site, 1 recruiting
- Recruiting
Hospital Luis Calvo Mackenna and Clínica Alemana de Santiago
Santiago, 7760016
Yalda Lucero, MD, PhD, +56 9 97330860, ylucero@gmail.com
Yalda Lucero, MD, PhD
Iran1 site, 1 recruiting
- Recruiting
Ahvaz Imam hospital
Ahvāz, Ahvaz, 6155873559
Pezhman Alavinejad
+989161115880, pezhmanalavinejad@gmail.com
Pakistan1 site, 1 recruiting
- Recruiting
Dow university of health sciences, Civil hospital Karachi
Karachi, 75500
Shahriyar Ghazanfar, MBBS, MRCS, +9221 99215740 ext. 3052, shahriyar.ghazanfar@duhs.edu.pk
Shahriyar Ghazanfar, MBBS, MRCS
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University
Szczecin
Wojciech Marlicz, MD, PhD, +48 91 425 32 31, marlicz@hotmail.com
Wojciech Marlicz, MD, PhD
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Damien Tan, MBBS, MRCP, +65 63265769, damien_tan@yahoo.com
Damien Tan, MBBS, MRCP
Taiwan1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, National Taiwan University Hospital
Taipei, 100
Wei-Chih Liao, MD, PhD, +886-2-23123456 ext. 63356, david.ntuh@gmail.com
Wei-Chih Liao, MD, PhD
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital
Istanbul, Istanbul, 34010
Bulent Baran, MD, FEBG, +90 850 250 8 250 ext. 29646, drbulentbaran@gmail.com
Bulent Baran, MD, FEBG
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Anastasios KOULAOUZIDIS, MD, FRCPE, +44 131 2421126, akoulaouzidis@hotmail.com
Anastasios KOULAOUZIDIS, MD, FRCPE
About this study
Official title: The Global Status and the Unmet Needs for Training in Endoscopy; a World Endoscopy Organization Web Based Survey
This is a 10 minutes web based survey aims at exploring the current, global state of digestive endoscopy training among physicians to identify what are the unmet needs and how to improve it.
Read the detailed description
Currently, gastrointestinal (GI) endoscopy training is not a standardized and is variable from country to country. A number of certifying authorities in different countries grant privileges of performing GI endoscopy according to predefined rules, requisites and regulations, especially in the Western countries (1-4). However, in many other countries, physicians who perform GI endoscopy as part of their medical practice may not require to be certified or acknowledged by a relevant regulatory body (5-8).
In the absence of quality assessment of GI training, patient safety and evidence-based medical care cannot be guaranteed. According to major societies of GI endoscopy, the credentialing decisions for GI endoscopy should be based on the evaluation of physicians' qualifications and procedural skills, as assessed by experienced doctors with whom they have trained, not solely on a simple counting of procedures performed (9). Therefore, there is a need for a WEO training guideline that defines training duration, procedural skills and competency that should be acquired by young GI endoscopists during their endoscopy training.
It is particularly important for WEO to standardize the fundamentals of GI endoscopy training globally by developing recommendations on endoscopic education and training to help medical institutions ensure the technical and cognitive competence of individuals requesting endoscopic privileges.
Objective:
To assess the current global state of GI endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire.
Methods:
Endoscopists from all over the world will be invited to answer in the questionnaire through e-mail invitations. Results will be analyzed to assess the current global status of GI endoscopy training in their countries, the unmet needs and to how improve it.
Survey link:
http://www.surveymonkey.net/create/survey/preview?r=true\&sm=R74C8rWWwbO8_2BQM2fg9Yr5HcAtrkz8XwZogb4Bbaqr8oC9mFJrq8WAvNY33O45r1
- Conditions
- Gastrointestinal Endoscopy Training
- Being tested
- Physician's opinion
- Keywords
- endoscopy, Education, capsule endoscopy, Cholangiopancreatography, Endoscopic Retrograde, esophagogastroduodenoscopy, colonoscopy, Double-Balloon Enteroscopy, Global status, unmet need
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician's opinionOther
To get physician's opinion about the current global state of gastrointestinal endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Training status
Number of certified endoscopy training centers all over the world
Measured: 8 months
Secondary outcomes (1)
Unmet needs
Identifying the unmet needs for endoscopy training all over the world
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Endoscopy TrainingStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alboraie, Al-Azhar University
- Investigators
- Mohamed Alboraie, MD, MRCP(UK), Principal investigator, Al-Azhay University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735655
- Sponsor's protocol ID
- WEO-ES-1
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Final results will be made available but not individual participant data.
Publications
Losowsky MS. Research, education, science, training. Work of the committees. British Society of Gastroenterology. Gut. 1987 Sep;28 Suppl(Suppl):25-6. No abstract available.
PubMed 3311912ASGE Training Committee; Adler DG, Bakis G, Coyle WJ, DeGregorio B, Dua KS, Lee LS, McHenry L Jr, Pais SA, Rajan E, Sedlack RE, Shami VM, Faulx AL. Principles of training in GI endoscopy. Gastrointest Endosc. 2012 Feb;75(2):231-5. doi: 10.1016/j.gie.2011.09.008. Epub 2011 Dec 7. No abstract available.
PubMed 22154419Rutter MD, Senore C, Bisschops R, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Bellisario C, Minozzi S, Hassan C, Rees C, Dinis-Ribeiro M, Hucl T, Ponchon T, Aabakken L, Fockens P. The European Society of Gastrointestinal Endoscopy Quality Improvement Initiative: developing performance measures. United European Gastroenterol J. 2016 Feb;4(1):30-41. doi: 10.1177/2050640615624631. Epub 2015 Dec 17.
PubMed 26966520Xiong X, Barkun AN, Waschke K, Martel M; Canadian Gastroenterology Training Program Directors. Current status of core and advanced adult gastrointestinal endoscopy training in Canada: Survey of existing accredited programs. Can J Gastroenterol. 2013;27(5):267-72. doi: 10.1155/2013/186284.
PubMed 23712301Makmun D. Present status of endoscopy, therapeutic endoscopy and the endoscopy training system in Indonesia. Dig Endosc. 2014 Apr;26 Suppl 2:2-9. doi: 10.1111/den.12245.
PubMed 24750141Ismaila BO, Misauno MA. Gastrointestinal endoscopy in Nigeria--a prospective two year audit. Pan Afr Med J. 2013;14:22. doi: 10.11604/pamj.2013.14.22.1865. Epub 2013 Jan 15.
PubMed 23503686Watermeyer G, Van Wyk ME, Goldberg PA. Audit of provincial gastroenterology services in the Western Cape. S Afr J Surg. 2008 Aug;46(3):68-72.
PubMed 18807301
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Global Status and the Unmet Needs for Training in Endoscopy; a World Endoscopy Organization Web Based Survey
- ClinicalTrials.gov ID
- NCT02735655
- Acronym / sponsor ID
- WEO-ES-1
- Conditions
- Gastrointestinal Endoscopy Training
- Keywords
- endoscopy, Education, capsule endoscopy, Cholangiopancreatography, Endoscopic Retrograde, esophagogastroduodenoscopy, colonoscopy, Double-Balloon Enteroscopy, Global status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 13 Apr 2016 (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 10 minutes web based survey aims at exploring the current, global state of digestive endoscopy training among physicians to identify what are the unmet needs and how to improve it.
Detailed description
Currently, gastrointestinal (GI) endoscopy training is not a standardized and is variable from country to country. A number of certifying authorities in different countries grant privileges of performing GI endoscopy according to predefined rules, requisites and regulations, especially in the Western countries (1-4). However, in many other countries, physicians who perform GI endoscopy as part of their medical practice may not require to be certified or acknowledged by a relevant regulatory body (5-8).
In the absence of quality assessment of GI training, patient safety and evidence-based medical care cannot be guaranteed. According to major societies of GI endoscopy, the credentialing decisions for GI endoscopy should be based on the evaluation of physicians' qualifications and procedural skills, as assessed by experienced doctors with whom they have trained, not solely on a simple counting of procedures performed (9). Therefore, there is a need for a WEO training guideline that defines training duration, procedural skills and competency that should be acquired by young GI endoscopists during their endoscopy training.
It is particularly important for WEO to standardize the fundamentals of GI endoscopy training globally by developing recommendations on endoscopic education and training to help medical institutions ensure the technical and cognitive competence of individuals requesting endoscopic privileges.
Objective:
To assess the current global state of GI endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire.
Methods:
Endoscopists from all over the world will be invited to answer in the questionnaire through e-mail invitations. Results will be analyzed to assess the current global status of GI endoscopy training in their countries, the unmet needs and to how improve it.
Survey link:
http://www.surveymonkey.net/create/survey/preview?r=true\&sm=R74C8rWWwbO8_2BQM2fg9Yr5HcAtrkz8XwZogb4Bbaqr8oC9mFJrq8WAvNY33O45r1
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians practicing gastrointestinal endoscopy
Key inclusion criteria (1 listed)
- Physicians practicing gastrointestinal endoscopy from all over the world
Key exclusion criteria (1 listed)
- Any other persons whom are not physicians or physicians not practicing gastrointestinal endoscopy
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 |
|---|---|---|
| Physician's opinionTo get physician's opinion about the current global state of gastrointestinal endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire. | Other | – |
Primary outcome
Training status
Time frame: 8 months
Number of certified endoscopy training centers all over the world
1 secondary outcome
Unmet needs
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Results publication: PubMed 3311912Losowsky MS. Research, education, science, training. Work of the committees. British Society of Gastroenterology. Gut. 1987 Sep;28 Suppl(Suppl):25-6. No abstract available.
- Results publication: PubMed 22154419ASGE Training Committee; Adler DG, Bakis G, Coyle WJ, DeGregorio B, Dua KS, Lee LS, McHenry L Jr, Pais SA, Rajan E, Sedlack RE, Shami VM, Faulx AL. Principles of training in GI endoscopy. Gastrointest Endosc. 2012 Feb;75(2):231-5. doi: 10.1016/j.gie.2011.09.008. Epub 2011 Dec 7. No abstract available.
- Results publication: PubMed 26966520Rutter MD, Senore C, Bisschops R, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Bellisario C, Minozzi S, Hassan C, Rees C, Dinis-Ribeiro M, Hucl T, Ponchon T, Aabakken L, Fockens P. The European Society of Gastrointestinal Endoscopy Quality Improvement Initiative: developing performance measures. United European Gastroenterol J. 2016 Feb;4(1):30-41. doi: 10.1177/2050640615624631. Epub 2015 Dec 17.
- Results publication: PubMed 23712301Xiong X, Barkun AN, Waschke K, Martel M; Canadian Gastroenterology Training Program Directors. Current status of core and advanced adult gastrointestinal endoscopy training in Canada: Survey of existing accredited programs. Can J Gastroenterol. 2013;27(5):267-72. doi: 10.1155/2013/186284.
- Results publication: PubMed 24750141Makmun D. Present status of endoscopy, therapeutic endoscopy and the endoscopy training system in Indonesia. Dig Endosc. 2014 Apr;26 Suppl 2:2-9. doi: 10.1111/den.12245.
- Results publication: PubMed 23503686Ismaila BO, Misauno MA. Gastrointestinal endoscopy in Nigeria--a prospective two year audit. Pan Afr Med J. 2013;14:22. doi: 10.11604/pamj.2013.14.22.1865. Epub 2013 Jan 15.
- Results publication: PubMed 18807301Watermeyer G, Van Wyk ME, Goldberg PA. Audit of provincial gastroenterology services in the Western Cape. S Afr J Surg. 2008 Aug;46(3):68-72.
- Survey linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Final results will be made available but not individual participant data.
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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.
Mohamed Alboraie, MD, MRCP(UK) principal investigator
Al-Azhay University, Cairo, Egypt
13 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Endoscopy Training, run by Al-Azhar University at 13 sites in 12 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Egypt, United States, Belgium, Brazil, Chile and 7 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Alboraie, MD (00201222717078, m.alboraie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training status (time frame: 8 months). 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 NCT02735655, which also lists 7 linked publications.
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 2 May 2016.