Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000086662
Ethics application status
Approved
Date submitted
17/01/2023
Date registered
25/01/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
25/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Matched comparison of gastro-enterostomy construction: Quantify differences in technical proficiency and precision of robotic versus laparoscopic platform.
Scientific title
Matched comparison of gastro-enterostomy construction: Quantify differences in technical proficiency and precision of robotic versus laparoscopic platform.
Secondary ID [1] 308764 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 328718 0
Condition category
Condition code
Diet and Nutrition 325730 325730 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 325231 0
Treatment: Surgery
Comparator / control treatment
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 laparoscopically is between 45 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.

Control group
Active

Outcomes
Primary outcome [1] 333579 0
Surgical precision measured using the Bariatric Objective Structured Assessment of technical skills (BOSATS).
Timepoint [1] 333579 0
At the time of procedure.
Primary outcome [2] 333616 0
Surgical precision measured using the Global Operative Assessment of Laparoscopic Skills (GOALS) or Global Evaluative Assessment of Robotic Skills (GEARS).
Timepoint [2] 333616 0
At the time of procedure
Secondary outcome [1] 417591 0
Surgeon workload during moderate to difficult surgical tasks measured using the National Aeronautics and Space Administration Task Load Index (NASA-TLX).
Timepoint [1] 417591 0
At the time of procedure.

Eligibility
Key inclusion criteria
Laparoscopic OR Robotic gastric bypass procedure:
a. Roux-en-Y gastric bypass (RYGB)
b. One anastomosis gastric bypass (OAGB)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Emergency or urgent surgery
2. Patient or next of kin with no capacity to provide consent for video recording

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A power calculation is performed a priori based on earlier work performed by Vassiliou et al. in the development of GOALS scale. The mean score of attending surgeons was 16.95 points with a standard deviation of 4.75 points. Based on our projected hypotheses of 20% increase in the proficiency score, using a power of 0.9, and alpha of 0.05, the minimum required number of videos for each group is 42.

Therefore, at least 42 videos in each group will be statistically powered to prove our hypotheses.


The mean and total GOALS, GEARS score and BOSATS score of both groups will be analysed and compared.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
28/06/2023
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
15/12/2024
Actual
Sample size
Target
82
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23843 0
The Avenue Private Hospital - Windsor
Recruitment hospital [2] 23844 0
The Alfred - Melbourne
Recruitment hospital [3] 23845 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [4] 26825 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [5] 26826 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [6] 26827 0
St George Private Hospital - Kogarah
Recruitment hospital [7] 26828 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [8] 26829 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 39298 0
3181 - Windsor
Recruitment postcode(s) [2] 39299 0
3004 - Melbourne
Recruitment postcode(s) [3] 39300 0
3144 - Malvern
Recruitment postcode(s) [4] 42880 0
6150 - Murdoch
Recruitment postcode(s) [5] 42881 0
5042 - Bedford Park
Recruitment postcode(s) [6] 42882 0
2217 - Kogarah
Recruitment postcode(s) [7] 42883 0
4224 - Tugun
Recruitment postcode(s) [8] 42884 0
4217 - Benowa

Funding & Sponsors
Funding source category [1] 312997 0
University
Name [1] 312997 0
Monash University
Country [1] 312997 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Faculty of Medicine and Nursing Health Science
Central Clinical School
Alfred Centre
99 Commercial Road
Melbourne, 3004, Victoria
Country
Australia
Secondary sponsor category [1] 314715 0
None
Name [1] 314715 0
None
Address [1] 314715 0
None
Country [1] 314715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312251 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312251 0
Ethics committee country [1] 312251 0
Australia
Date submitted for ethics approval [1] 312251 0
20/02/2023
Approval date [1] 312251 0
23/06/2023
Ethics approval number [1] 312251 0
91593(ref89/23)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123994 0
Dr Yit Leang
Address 123994 0
Department of Surgery (Monash University)
Central Clinical School
Level 6, Alfred Centre
99 Commercial Road
Melbourne, 3004
Victoria
Country 123994 0
Australia
Phone 123994 0
+61399030190
Fax 123994 0
Email 123994 0
[email protected]
Contact person for public queries
Name 123995 0
Yit Leang
Address 123995 0
Department of Surgery (Monash University)
Central Clinical School
Level 6, Alfred Centre
99 Commercial Road
Melbourne, 3004
Victoria
Country 123995 0
Australia
Phone 123995 0
+61399030190
Fax 123995 0
Email 123995 0
[email protected]
Contact person for scientific queries
Name 123996 0
Yit Leang
Address 123996 0
Department of Surgery (Monash University)
Central Clinical School
Level 6, Alfred Centre
99 Commercial Road
Melbourne, 3004
Victoria
Country 123996 0
Australia
Phone 123996 0
+61399030190
Fax 123996 0
Email 123996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.