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

NCT01811095 | Completed DMC

• 1 other identifier: A01-M10-13B
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Keywords

Robotics; Computer-assisted surgery; Computer simulation; Gynecology; General surgery

Outcome Measures

Primary Outcomes (1)

• Ability to suture an inanimate model with the da Vinci Surgical System

  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.

  5 weeks

Secondary Outcomes (2)

• Scoring Performance of the Virtual Reality Tasks Performed with the da Vinci® Skills Simulator

  5 weeks

• 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

  5 weeks

Study Arms (2)

Training arm

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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.

Interventions

Training OTHER

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.

Training arm

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• McGill University: lead

Study Sites (2)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• 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.

  PMID: 26531197 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daniel J Kiely, MDCM FRCSC

  McGill University

  PRINCIPAL INVESTIGATOR

• Joshua Z Press, MD MSc FRCSC

  McGill University, Jewish General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDCM FRCSC, MSc candidate

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

CA (2)