ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Controlled Trial of a Robotic Simulation Curriculum to Teach Robotic Suturing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01811095
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : September 12, 2013
Sponsor:
Information provided by (Responsible Party):
Daniel James Kiely, McGill University

Brief Summary:
The aim of this study is to determine if training with a robotic simulator improves ability to perform robotic suturing. We aim to recruit 38 participants (attending surgeons or residents in obstetrics and gynecology, urology, general surgery, or cardiac surgery). Participants will be randomized to training with a virtual reality robotic simulator in addition to clinical work or to usual clinical work alone for a period of 5 weeks. They will be tested at baseline and post-intervention in the task of suturing a inanimate model with the actual surgical robot. After the initial study period, the control group will have the opportunity to cross over and complete the training and then re-testing.

Condition or disease Intervention/treatment Phase
Neoplasms Other: Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: A Randomized Controlled Trial of a Robotic Simulation Curriculum to Teach Robotic Suturing
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Training arm
The training arm participates in the robotic suturing simulation curriculum, a "proficiency" curriculum that it is focused on the goal of achieving proficiency targets for five simulator tasks. Those six tasks are : Camera targeting 1, Camera targeting 2, Suture sponge 1, Suture sponge 2, and Suture sponge 3. The curriculum also includes a sixth task, Suturing Skills (Symbionix): Horizontal suturing defect. Participants are encouraged to complete this task ten times rather than to attain a certain score. Participants set their own hours about when and how much to train during the 5 week intervention period. They are instructed that approximately one hour per week over 5 weeks will be required to achieve the targets, on average.
Other: Training
Training with the da Vinci® Skills Simulator to complete a proficiency-based curriculum in 6 simulator exercises relevant to robotic suturing over a 5-week period. We will ask participants in the training group to aim to complete the exercises Camera targeting 1, Camera targeting 2, Suture sponge 1, Suture sponge 2,and Suture sponge 3 to the target score (overall score green checkmark and all component scores to the level of yellow triangle or green checkmark, equivalent to a "completed score") on two non-consecutive attempts. For the "Suturing skills (SymbionixTM): Horizontal suturing defect" task, the scoring is different. For this task, we have elected to ask participants to aim to complete the task ten times,rather than to achieve a certain target score.

Placebo Comparator: Control
Participants in this group carry on with regular training (residents) or regular clinical work (attending surgeons) without robotic simulator training during the five week period when they are in the control group.



Primary Outcome Measures :
  1. Ability to suture an inanimate model with the da Vinci Surgical System [ Time Frame: 5 weeks ]
    Participants will suture an inanimate model of the vaginal cuff using the da Vinci Surgical System. The performance of this task will be videotaped using the da Vinci Surgical System's built in camera. Surgical video will be scored by one expert robotic surgeon, one surgeon with intermediate robotic experience, and one gynecologic oncology fellow, blinded to intervention group, participant identity, participant experience level, and pre- versus post-intervention status. Surgical video will be scored using the Global Operative Assessment of Laparoscopic Skills (GOALS) in addition to two additional metrics developed by AJ Hung et al specifically for robotics: 1) instrument and camera awareness and 2) precision. The GOALS score contains 5 domains. The 5 domains of the GOALS score and the two additional domains developed by AJ Hung et al are each scored on a 5 point Likert scale providing a maximum possible score of 35 per rater and 70 overall.


Secondary Outcome Measures :
  1. Scoring Performance of the Virtual Reality Tasks Performed with the da Vinci® Skills Simulator [ Time Frame: 5 weeks ]
    Performance of the five selected tasks (Camera targeting 1, Camera targeting 2, Suture sponge 1, Suture sponge 2, and Suture sponge 3) will be assessed using the built in metrics of the da Vinci® Skills Simulator. The scoring will be out of 100 as per the M-score algorithm of the da Vinci® Skills Simulator. Data on this secondary outcome are collected automatically by the simulator as participants train and on the testing days for suture sponge 1.

  2. Number of total knots and of satisfactory knots tied when using the da Vinci Surgical System to suture an inanimate model of the vaginal cuff [ Time Frame: 5 weeks ]
    When participants suture the inanimate model of the vaginal cuff on pre-test and post-test days, the number of total knots and the number satisfactory knots tied will also be considered as a secondary outcome. This will be assessed by blinded review of video taped performance by one expert robotic surgeon, one surgeon with intermediate robotic experience, and one gynecologic oncology fellow. "Satisfactory" knots are defined as knots which the assessor of the video would not cut out and re-do in actual surgery. Note that although this outcome is being added on May 13 and thus, after the start of the study, blinded review of video will not start until after the final testing day on June 1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • resident or attending surgeon in the department of General Surgery, Obstetrics and Gynecology, Cardiac Surgery, or Urology at McGill University or affiliated teaching hospitals

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811095


Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Daniel J Kiely, MDCM FRCSC McGill University
Study Chair: Joshua Z Press, MD MSc FRCSC McGill University, Jewish General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel James Kiely, MDCM FRCSC, MSc candidate, McGill University
ClinicalTrials.gov Identifier: NCT01811095     History of Changes
Other Study ID Numbers: A01-M10-13B
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Daniel James Kiely, McGill University:
Robotics
Computer-assisted surgery
Computer simulation
Gynecology
General surgery