Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation

This study compared the learning curves and outcome of Laparoscopic Distal Pancreatectomy between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes.

Study Overview

Status

Completed

Conditions

Detailed Description

Learning curves of laparoscopic distal pancreatectomy (LDP) are mostly based on 'pioneering' surgeons who acquired sufficient proficiency largely through self-teaching. No learning curves have been investigated for early adopting surgeons who performed surgery in later stages of the IDEAL framework and build on the experience of the 'pioneering' surgeons. This study compared the learning curves and outcome of LDP between 'pioneers' and early adopters in terms of feasibility and proficiency using short term outcomes over a period from 1997-2019.

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data of all consecutive patients who underwent elective LDP by 'pioneering' surgeons and early adopting surgeons in the period 1997-2019 were collected from a retrospective database of centers participating in the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) or International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS).

Description

Inclusion Criteria:

  • The collected data included the name of the surgeon so inclusion criteria for participating surgeons could be determined. Surgeons who were experienced with a minimum of 40 LDPs in total with at least 10 LDPs per year and who performed their LDPs in the same institution (i.e. no outside institutions) were included.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early adopting surgeons
Surgeons who started performing LDP during phase 3 of the IDEAL framework; the Assessment phase. They received training in the form of fellowships, proctoring, and courses
Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups
Pioneering surgeons
Surgeons who started performing LDP during phase 2 of the IDEAL framework; the Development and Exploration phase. They did not receive any specific form of training and were therefore considered self-taught.
Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility learning curve
Time Frame: 1997-2019
Feasibility learning curves are based on operation time
1997-2019
Proficiency learning curve
Time Frame: 1997-2019
Proficiency learning curves are based on major complications
1997-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 1997

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • W19_414 # 19.482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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