SurgeryNCT05595343
Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation
An observational study of Surgery, run by Fondazione Poliambulanza Istituto Ospedaliero.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- Laparoscopic distal pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 1997to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- None
About this study
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Laparoscopic distal pancreatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic distal pancreatectomyProcedure or surgery
Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laparoscopic distal pancreatectomy | |
| 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. Receives: Procedure: Laparoscopic distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility learning curve
Feasibility learning curves are based on operation time
Measured: 1997-2019
Proficiency learning curve
Proficiency learning curves are based on major complications
Measured: 1997-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study startDec 1997
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595343
- Sponsor's protocol ID
- W19_414 # 19.482
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Ramshorst TME, Edwin B, Han HS, Nakamura M, Yoon YS, Ohtsuka T, Tholfsen T, Besselink MG, Abu Hilal M. Learning curves in laparoscopic distal pancreatectomy: a different experience for each generation. Int J Surg. 2023 Jun 1;109(6):1648-1655. doi: 10.1097/JS9.0000000000000408.
PubMed 37144678
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curves in Laparoscopic Distal Pancreatectomy: A Different Experience for Each Generation
- ClinicalTrials.gov ID
- NCT05595343
- Acronym / sponsor ID
- W19_414 # 19.482
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- Dec 1997 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early adopting surgeons | – | Procedure: Laparoscopic distal pancreatectomySurgeons 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 |
| Pioneering surgeons | – | Procedure: Laparoscopic distal pancreatectomySurgeons 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic distal pancreatectomyComparison of performed laparoscopic distal pancreas surgery in two different surgeon groups | Procedure or surgery | Early adopting surgeons, Pioneering surgeons |
Primary outcome
Feasibility learning curve
Time frame: 1997-2019
Feasibility learning curves are based on operation time
Proficiency learning curve
Time frame: 1997-2019
Proficiency learning curves are based on major complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 37144678van Ramshorst TME, Edwin B, Han HS, Nakamura M, Yoon YS, Ohtsuka T, Tholfsen T, Besselink MG, Abu Hilal M. Learning curves in laparoscopic distal pancreatectomy: a different experience for each generation. Int J Surg. 2023 Jun 1;109(6):1648-1655. doi: 10.1097/JS9.0000000000000408.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Fondazione Poliambulanza Istituto Ospedaliero.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility learning curve (time frame: 1997-2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.