Back to resultsEvaluation of Difficulty Score for Robotic Pancreatoduodenectomy
Primary Purpose
Pancreatic Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Difficulty score system for robotic pancreatoduodenectomy
Sponsored by
About this trial
This is an interventional other trial for Pancreatic Neoplasm
Eligibility Criteria
Inclusion Criteria:
- pathology of the head of pancreas requiring surgery
Exclusion Criteria:
- pathology of the head of pancreas not requiring surgery
Sites / Locations
- Division of pancreatic surgery
- University of Pisa
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients undergoing robotic pancreatoduodenectomy
Arm Description
patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy
Outcomes
Primary Outcome Measures
correlation to post-operative complication
the score increase as complications increase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04662346
Brief Title
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy
Official Title
Difficulty Scoring System in Robotic Pancreatoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.
Detailed Description
Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients undergoing robotic pancreatoduodenectomy
Arm Type
Other
Arm Description
patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy
Intervention Type
Other
Intervention Name(s)
Difficulty score system for robotic pancreatoduodenectomy
Intervention Description
calculate the score for patient in you cohort
Primary Outcome Measure Information:
Title
correlation to post-operative complication
Description
the score increase as complications increase
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathology of the head of pancreas requiring surgery
Exclusion Criteria:
pathology of the head of pancreas not requiring surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ugo boggi
Organizational Affiliation
University of Pisa
Official's Role
Study Chair
Facility Information:
Facility Name
Division of pancreatic surgery
City
Pisa
ZIP/Postal Code
56125
Country
Italy
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56125
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
creation of the formula, validation
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
surgeon
Learn more about this trial
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy
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