Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy

NCT04662346 | Unknown

• 1 other identifier: Difficulty Score RPD
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• correlation to post-operative complication

  the score increase as complications increase

  6 months

Study Arms (1)

patients undergoing robotic pancreatoduodenectomy

OTHER

patients have pancreatic neoplasm and undergoing robotic pancreatoduodenectomy

Other: Difficulty score system for robotic pancreatoduodenectomy

Interventions

Difficulty score system for robotic pancreatoduodenectomy OTHER

calculate the score for patient in you cohort

patients undergoing robotic pancreatoduodenectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pathology of the head of pancreas requiring surgery

You may not qualify if:

• pathology of the head of pancreas not requiring surgery

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (2)

Division of pancreatic surgery

Pisa, 56125, Italy

Location

University of Pisa

Pisa, 56125, Italy

Location

Related Publications (1)

• 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.

  PMID: 36973127 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• ugo boggi

  University of Pisa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 10, 2020
• Study Start: December 1, 2020
• Primary Completion: January 20, 2021
• Study Completion: February 28, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 month
• Access Criteria: surgeon

Locations

IT (2)