- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662346
Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy
December 5, 2020 updated by: Concetta Cacace, University of Pisa
Difficulty Scoring System in Robotic Pancreatoduodenectomy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pisa, Italy, 56125
- University of Pisa
-
Pisa, Italy, 56125
- Division of pancreatic surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pathology of the head of pancreas requiring surgery
Exclusion Criteria:
- pathology of the head of pancreas not requiring surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: patients undergoing robotic pancreatoduodenectomy
patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy
|
calculate the score for patient in you cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation to post-operative complication
Time Frame: 6 months
|
the score increase as complications increase
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: ugo boggi, University of Pisa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2020
Primary Completion (ANTICIPATED)
January 20, 2021
Study Completion (ANTICIPATED)
February 28, 2021
Study Registration Dates
First Submitted
November 30, 2020
First Submitted That Met QC Criteria
December 5, 2020
First Posted (ACTUAL)
December 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 10, 2020
Last Update Submitted That Met QC Criteria
December 5, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Difficulty Score RPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
creation of the formula, validation
IPD Sharing Time Frame
6 month
IPD Sharing Access Criteria
surgeon
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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