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Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

NCT ID: NCT04662346

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-02-28

Brief Summary

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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

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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).

Conditions

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Pancreatic Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients undergoing robotic pancreatoduodenectomy

patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy

Group Type OTHER

Difficulty score system for robotic pancreatoduodenectomy

Intervention Type OTHER

calculate the score for patient in you cohort

Interventions

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Difficulty score system for robotic pancreatoduodenectomy

calculate the score for patient in you cohort

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pathology of the head of pancreas requiring surgery

Exclusion Criteria

* pathology of the head of pancreas not requiring surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Concetta Cacace

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ugo boggi

Role: STUDY_CHAIR

University of Pisa

Locations

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Division of pancreatic surgery

Pisa, , Italy

Site Status

University of Pisa

Pisa, , Italy

Site Status

Countries

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Italy

References

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Napoli N, Cacace C, Kauffmann EF, Jones L, Ginesini M, Gianfaldoni C, Salamone A, Asta F, Ripolli A, Di Dato A, Busch OR, Cappelle ML, Chao YJ, de Wilde RF, Hackert T, Jang JY, Koerkamp BG, Kwon W, Lips D, Luyer MDP, Nickel F, Saint-Marc O, Shan YS, Shen B, Vistoli F, Besselink MG, Hilal MA, Boggi U; International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS). The PD-ROBOSCORE: A difficulty score for robotic pancreatoduodenectomy. Surgery. 2023 Jun;173(6):1438-1446. doi: 10.1016/j.surg.2023.02.020. Epub 2023 Mar 25.

Reference Type DERIVED
PMID: 36973127 (View on PubMed)

Other Identifiers

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Difficulty Score RPD

Identifier Type: -

Identifier Source: org_study_id