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Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

U

University of Pisa

Status

Unknown

Conditions

Pancreatic Neoplasm

Treatments

Other: Difficulty score system for robotic pancreatoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04662346
Difficulty Score RPD

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • pathology of the head of pancreas requiring surgery

Exclusion criteria

  • pathology of the head of pancreas not requiring surgery

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,000 participants in 1 patient group

patients undergoing robotic pancreatoduodenectomy
Other group
Description:
patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy
Treatment:
Other: Difficulty score system for robotic pancreatoduodenectomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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