None listed
Conditions
Brief summary
The technical advantages of the robotic surgical platform have been embraced by surgeons but scientific quantification of the advantages when compared to conventional laparoscopic platform is scarce. Accurate measurement of such mechanical advantages in specific surgical procedures such as obesity surgery will be beneficial to assist surgeons in selecting the best surgical platform or tools to perform complex bariatric procedures with the aim of achieving the best surgical outcomes. This project will analyse and compare surgical recordings of surgeons constructing gastro-jejunal anastomosis in gastric bypass surgery using the robotic surgical platform and conventional laparoscopic platform. The video analysis will be correlated against the difficulty of the procedure measured using the National Aeronautics and Space Administration Task Load Index (NASA TLX), a short survey regarding the performance of the gastrointestinal anastomosis and clinical outcome parameters. The project will be open to all bariatric surgeons in Australia with the aim of recruiting 50 patients in each group. A total of at least 42 patients in each group will provide the adequate volume to power the study to detect a difference in surgical proficiency between the platforms.
Interventions
Intervention = Robotic Gastric bypass procedure (one anastomosis gastric/Roux-en-Y gastric bypass) for obesity
Eligible patient undergoing a gastric bypass procedure for obesity by a participating bariatric surgeon will be invited to participate.
The decision to perform the gastric bypass procedure robotically or laparoscopically would be based on the patient's bariatric surgeon recommendation along with patient's consent. Robotic gastric bypass patients will be recruited as intervention and
Intervention = Robotic Gastric bypass procedure (one anastomosis gastric/Roux-en-Y gastric bypass) for obesity Eligible patient undergoing a gastric bypass procedure for obesity by a participating bariatric surgeon will be invited to participate. The decision to perform the gastric bypass procedure robotically or laparoscopically would be based on the patient's bariatric surgeon recommendation along with patient's consent. Robotic gastric bypass patients will be recruited as intervention and laparoscopic gastric bypass will be recruited as the control treatment group. Once the specific procedure and mode of surgery has been decided, a clear explanation of conduct of the study will be provided by the surgeon to the patient. There will be no alteration to the surgical treatment in which the patient will receive from his or her bariatric surgeon. Patient who agree to participate in this study will give consent to his/her surgeon to record the intraabdominal component of the surgical procedure and collect some basic non-identifiable health information for this purpose of this study. Following completion of the procedure, the surgeon and his/her team will complete a short survey regarding the difficulty of the procedure. If the patient decide not to participate in the study, the surgery will proceed as planned without the video recording and survey. The procedure will be performed by the patient's bariatric surgeon as planned and explained by the participating surgeon to the patient. The approximately duration of a gastric bypass performed robotically is between 70 minutes to 180 minutes. This large variation in procedural time is largely dependant on the specific anatomy and surgical access to the stomach. The principal investigator will be in contact with all participating surgeons on a weekly basis to remind and encourage participating surgeons to enrol their upcoming eligible cases for the study. All surgical recordings and surveys will be collected within 2 working days following completion of the case to ensure all the necessary information are collected appropriately.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Laparoscopic OR Robotic gastric bypass procedure: a. Roux-en-Y gastric bypass (RYGB) b. One anastomosis gastric bypass (OAGB)
Exclusion criteria
Exclusion criteria 1. Emergency or urgent surgery 2. Patient or next of kin with no capacity to provide consent for video recording
Outcome results
None listed