Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01119027
First received: April 29, 2010
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to improve the investigators understanding of different training methods in laparoscopic colon surgery.


Condition
Colonic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • To observe and assess surgical technique used by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To evaluate technical errors and patterns of error by surgeons and surgeon trainees during training of laparoscopic colectomy. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Enrollment: 83
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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. .
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Surgeons and trainee surgeons attending laparoscopic colorectal training courses.

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119027

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Conor P Delaney, MD, PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Conor Delaney, MD, PhD, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01119027     History of Changes
Other Study ID Numbers: 07-09-04, 07-09-04
Study First Received: April 29, 2010
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Laparoscopic Colectomy
Colorectal Skills Training

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014