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

Completed

• Conditions: Robotic Pancreaticoduodenectomy

• Registration Number: NCT06723847
• Lead Sponsor: University of Pisa

Brief Summary

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.

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 Timeline

• Study Start: 2008-06-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-06-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

All patients underwent robotic pancreaticoduodenectomy.

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative complications	90 days	90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)