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

• ClinicalTrials.gov Identifier: NCT01811095
• Recruitment Status: Completed
• First Posted: March 14, 2013
• Last Update Posted: September 12, 2013
• Sponsor: McGill University
• Information provided by (Responsible Party): Daniel James Kiely, McGill University

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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:

-

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kiely DJ, Gotlieb WH, Lau S, Zeng X, Samouelian V, Ramanakumar AV, Zakrzewski H, Brin S, Fraser SA, Korsieporn P, Drudi L, Press JZ. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial. J Robot Surg. 2015 Sep;9(3):179-86. doi: 10.1007/s11701-015-0513-4. Epub 2015 May 16.

• 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
• 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