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OpenTrials
Completed

NCT Number: NCT06723847

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients underwent robotic pancreaticoduodenectomy.

Exclusion criteria

None.

Treatment and study plan

Robotic pancreaticoduodenectomy

Procedure

All procedures are performed used a standard technique of our center for robotic pancreaticoduodenectomy

Other names: robotic Whipple, robot-assisted pancreaticoduodenectomy, robot-assisted Whipple

Primary outcomes

  1. Post-operative complications

    Time frame: 90 days

    90-day post-operative complications assessed by the Comprehensive Complication Index (CCI)

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Acronym: LC-RPD

Important dates

Study start
2008
Primary completion
2023
Study completion
2024
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.