- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595343
Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation
October 24, 2022 updated by: Fondazione Poliambulanza Istituto Ospedaliero
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
Intervention / Treatment
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.
Collaborators
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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