NCT05595343

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 1997

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
22 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

22 years

First QC Date

October 18, 2022

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Feasibility learning curve

    Feasibility learning curves are based on operation time

    1997-2019

  • Proficiency learning curve

    Proficiency learning curves are based on major complications

    1997-2019

Study Arms (2)

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

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.

Procedure: Laparoscopic distal pancreatectomy

Interventions

Comparison of performed laparoscopic distal pancreas surgery in two different surgeon groups

Early adopting surgeonsPioneering surgeons

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 26, 2022

Study Start

December 1, 1997

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share