Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

NCT01371136 | Completed

• 1 other identifier: SMH10-059
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training. The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial. The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient. The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.

Conditions

Education; Simulation; Technical Skills Training; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Difference in operating room performance between intervention and control group

  Surgical residents participating in the study will perform a laparoscopic right colectomy in the operating room. The procedure will be video-recorded through the laparoscopic camera. The videos will be given to a blinded expert in video assessment who will assess the technical proficiency of the resident using a validated global rating scale.

  5 months from intervention

Secondary Outcomes (2)

• Difference in cognitive knowledge between intervention and control group

  5 months from the intervention

• Difference in technical performance on the virtual reality simulator between intervention and control group residents

  5 months from intervention

Study Arms (2)

Curricular Trained

EXPERIMENTAL

Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.

Procedure: curricular training

conventional residency training

NO INTERVENTION

These residents proceed through surgical residency training as usual

Interventions

curricular training PROCEDURE

Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an "easy", "medium" and "hard" level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver.

Curricular Trained

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• resident in general surgery
• post graduate year (PGY) 2 or higher
• performed less than 10 laparoscopic colorectal procedures independently

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Royal College of Physicians and Surgeons of Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5R3C3, Canada

Location

Related Publications (1)

• Palter VN, Grantcharov TP. Development and validation of a comprehensive curriculum to teach an advanced minimally invasive procedure: a randomized controlled trial. Ann Surg. 2012 Jul;256(1):25-32. doi: 10.1097/SLA.0b013e318258f5aa.

  PMID: 22664557 DERIVED

Study Officials

• Teodor P Grantcharov, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CA (1)