NCT04429074

Brief Summary

This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

29 days

First QC Date

June 9, 2020

Last Update Submit

June 9, 2020

Conditions

Minimally Invasive Distal Pancreatectomy

Keywords

Benign or borderline pathology (non-pancreatic cancer)laparoscopyregistrarpostoperative outcomespancreatectomysurgerypancreas

Outcome Measures

Primary Outcomes (1)

  • open conversion rate

    Necessity to swith from minimally invasive approach to open approach during laparoscopy

    1 day

Secondary Outcomes (9)

  • Duration of surgery

    1 day

  • Intraoperative bloodloss

    1 day

  • Intraoperative transfusion

    1 day

  • severe complications Clavien Dindo>3

    90 days postoperative

  • postoperative complications

    90 days postoperative

  • +4 more secondary outcomes

Study Arms (2)

Group 1 (Registrar)

Group 1 (Registrar): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a registrar (young specialist surgeon)

Procedure: Minimally invasive distal pancreatectomy

Group 2 (Consultant)

Group 2 (Consultant): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a consultant (expert)

Procedure: Minimally invasive distal pancreatectomy

Interventions

Minimally invasive distal pancreatectomyPROCEDURE

Minimally invasive distal pancreatectomy

Group 1 (Registrar)Group 2 (Consultant)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology

You may qualify if:

  • \- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology between 2009-2020

You may not qualify if:

  • open distal pancreatectomy
  • minimally invasive distal pancreatectomy for pancreatic cancer
  • first consecutive patients operated on by the consultant (learning curve)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

  • REGIS SOUCHE

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

December 1, 2019

Primary Completion

December 30, 2019

Study Completion

June 1, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

FR(1)