Navigating the Learning Curve of Robotic Pancreatoduodenectomy: Feasibility, Proficiency, and Mastery in a First-generation Surgeon (LC-RPD)

This study delineates the learning curve of robotic pancreatoduodenectomy (RPD) for first-generation surgeons, using the Comprehensive Complication Index (CCI) to assess patient outcomes and the PD-ROBOSCORE to stratify patients for their risk to develop post-operative complications.

Study Overview

• Status: Completed
• Conditions: Robotic Pancreaticoduodenectomy
• Intervention / Treatment: Procedure: Robotic pancreaticoduodenectomy

Detailed Description

This study aims to define the learning curve of a first-generation surgeon who implemented robotic pancreatoduodenectomy. When compared to previous studies on the same issue, the current study has several distinctive features. Firstly, the learning curve was defined using the cumulative sum method, with the comprehensive complication index as the main outcome metric. The comprehensive complication index provides a holistic view of the burden of postoperative complications in each individual patient, correlating with key outcome measures such as length of hospital stay, use of hospital resources, and ultimately mortality. Secondly, outcomes were adjusted by procedure complexity based on the newly described PD-ROBOSCORE (Surgery. 2023;173:1438-1446). This is the first study assessing the learning curve of robotic pancreatoduodenectomy while incorporating difficulty levels.

• Study Type: Observational
• Enrollment (Actual): 313

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patient underwent robotic pancreaticoduodenectomy at our institution regardless for the pathology

Description

Inclusion Criteria:

All patients underwent robotic pancreaticoduodenectomy.

Exclusion Criteria:

None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient underwent robotic pancreaticoduodenectomy; All patients undergoing robotic pancreaticoduodenectomy regardless of the pathology for which they underwent it	Procedure: Robotic pancreaticoduodenectomy; All procedures are performed used a standard technique of our center for robotic pancreaticoduodenectomy; Other Names: robotic Whipple; robot-assisted pancreaticoduodenectomy; robot-assisted Whipple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)	90 days

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: learning curve; robotic pancreaticoduodenectomy
• Other Study ID Numbers: LC-RPD-Boggi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: They will be shared upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No