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Completed

NCT Number: NCT04429074

Registrar Performances in MIDP

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

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Key information

Conditions

Minimally Invasive Distal Pancreatectomy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Minimally invasive distal pancreatectomy

Procedure

Minimally invasive distal pancreatectomy

Primary outcomes

  1. open conversion rate

    Time frame: 1 day

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

Secondary outcomes

  1. Duration of surgery

    Time frame: 1 day

    Duration of surgery

  2. Intraoperative bloodloss

    Time frame: 1 day

    Intraoperative bloodloss

  3. Intraoperative transfusion

    Time frame: 1 day

    Intraoperative transfusion

  4. severe complications Clavien Dindo>3

    Time frame: 90 days postoperative

    severe complications Clavien Dindo>3

  5. postoperative complications

    Time frame: 90 days postoperative

    postoperative complications

  6. clinically relevant postoperative fistula

    Time frame: 90 days postoperative

    clinically relevant postoperative fistula (2016 ISGPF definition)

  7. lenght of hospital stay

    Time frame: 90 days postoperative

    lenght of hospital stay

  8. readmission rate

    Time frame: 90 days postoperative

    readmission rate

  9. reoperation rate

    Time frame: 90 days postoperative

    reoperation rate

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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