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- Klinische proef NCT01119027
Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
In this study the investigators use an objective evaluation system which deconstructs laparoscopic colectomy into its component steps. Critical components of the procedure as well as overall operative performance can be evaluated. This is applied to surgeons and trainee surgeons attending laparoscopic colorectal training courses using different training models to compare each model and correlate outcomes with each model to pre-course experience. This project is aimed at better educating trainers and getting better information on the validity of new training models for laparoscopic colectomy.
Aims of Project
- To observe and assess surgical technique during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
- To evaluate technical errors and patterns of error during training at laparoscopic colectomy.
- To determine outcomes and error rates with different training models and correlate these with prior surgical experience.
Number of participants/subjects in research:
Subjects will be recruited in several sites:
- the principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
- Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
- American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
Course attendees will be informed before the start of an appropriate laparoscopic course that the study is being performed. The study will be explained to them in detail and they will be given a copy of the appropriate paperwork to review. Verbal consent will be requested. It will be explained to them that they should feel under no pressure to participate in the study, and that if they do participate that these data are not used for their evaluation. The number of cases of components of cases that they perform will not be related to participation or non-participation in the trial.
Study Design This is an observational study in which trainees' technical surgical skills are evaluated while performing specific steps of laparoscopic colectomy cases, as outlined in the accompanying datasheets. The plan is to enroll 200 participants.
At the completion of each case, forms will be completed by the trainee, and by the teaching / supervising surgeon. Independent observers cannot be used, as only an attending laparoscopic colorectal surgeon is adequately skilled to score the resident performing the case, and it is not feasible to have a second attending surgeon present during each case.
Dr Delaney will score trainees when possible using the standardized form. For courses at University Hospitals Case Medical Center (UHCMC), the colorectal faculty will be instructed in standardized assessment, and will also assess trainees. For courses at SAGES or ASCRS, the course faculty will be shown the training assessments and directed in the standardized assessment prior to evaluations.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- University Hospitals Case Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
Subjects will be recruited in several sites:
- The principal investigators facility at University Hospitals of Cleveland Case Medical Center, where surgeons from outside institutions visit regularly for training courses
- Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
- American Society of Colorectal Surgeons (ASCRS) Laparoscopic colorectal training courses, where surgeons participate in courses with invited faculty at national meetings (the PI is national Program Director and runs these courses).
Exclusion Criteria:
Not applicable
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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Surgeons
Surgeons and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience. .
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Trainee Surgeons
Surgeon and trainee surgeons attending laparoscopic colorectal training courses will be recruited to study using different training models to compare each model and correlate outcomes with each model to pre-course experience.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To observe and assess surgical technique used by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses.
Tijdsspanne: one year
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To observe and assess surgical technique by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses using a previously validated tool for formal assessment of surgical technical skills.
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one year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To evaluate technical errors and patterns of error by surgeons and surgeon trainees during training of laparoscopic colectomy.
Tijdsspanne: one year
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To evaluate technical errors and patterns of error of surgeons and surgeon trainees during training at laparoscopic colectomy.
To determine outcomes and error rates with different training models and correlate these with prior surgical experience
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one year
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Conor P Delaney, MD, PhD, University Hospitals Cleveland Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 07-09-04 (Andere identificatie: Unversity Hospitals Case Medical Center)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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