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

  • Italy
      • 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
Other: Difficulty score system for 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

University of Pisa

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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