Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills

NCT01119027 | Terminated DMC

• 1 other identifier: 07-09-04
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonic Diseases

Keywords

Laparoscopic Colectomy; Colorectal Skills Training

Outcome Measures

Primary Outcomes (1)

• To observe and assess surgical technique used by surgeons and surgeon trainees in attendance during laparoscopic colorectal skills training courses.

  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.

  one year

Secondary Outcomes (1)

• To evaluate technical errors and patterns of error by surgeons and surgeon trainees during training of laparoscopic colectomy.

  one year

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgeons and trainee surgeons attending laparoscopic colorectal training courses.

You may qualify if:

• 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).

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Conor P Delaney, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 7, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 15, 2014

Record last verified: 2012-11

Locations

US (1)