Colonic Diseases Clinical Trial
Official title:
Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills
The purpose of this study is to improve the investigators understanding of different training methods in laparoscopic colon surgery.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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