Registrar Performances in MIDP

NCT ID: NCT04429074

Last Updated: 2020-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-06-01

Brief Summary

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

Detailed Description

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From January 2009 to March 2020, data of all consecutive patients requiring distal pancreatectomy in our public tertiary hospital were prospectively collected and retrospectively analyzed.

Registrars were progressively involved for MIDP since 2009 and their experience was: \< 5 open pancreatic resections, \< 5 MIDP and at least 30 advanced minimally invasive gastrointestinal resections.

Outcome of patients who underwent either distal pancreatectomy by the consultant or registrars were compared.

Our primary outcome was the conversion rate. The secondary outcomes were 90-days postoperative outcomes including CR-POPF defined and classified according to the 2016 ISGPF definition.

Conditions

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Minimally Invasive Distal Pancreatectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

Minimally invasive distal pancreatectomy

Intervention Type 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)

Minimally invasive distal pancreatectomy

Intervention Type PROCEDURE

Minimally invasive distal pancreatectomy

Interventions

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Minimally invasive distal pancreatectomy

Minimally invasive distal pancreatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* open distal pancreatectomy
* minimally invasive distal pancreatectomy for pancreatic cancer
* 20 first consecutive patients operated on by the consultant (learning curve)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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REGIS SOUCHE

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0348

Identifier Type: -

Identifier Source: org_study_id

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