2019-12-01
2019-12-30
2020-06-01
71
NCT04429074
University Hospital, Montpellier
University Hospital, Montpellier
OBSERVATIONAL
Registrar Performances in MIDP
This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-06-09 | N/A | 2020-06-09 |
2020-06-09 | N/A | 2020-06-12 |
2020-06-12 | N/A | 2020-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| open conversion rate | Necessity to swith from minimally invasive approach to open approach during laparoscopy | 1 day |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of surgery | Duration of surgery | 1 day |
| Intraoperative bloodloss | Intraoperative bloodloss | 1 day |
| Intraoperative transfusion | Intraoperative transfusion | 1 day |
| severe complications Clavien Dindo>3 | severe complications Clavien Dindo>3 | 90 days postoperative |
| postoperative complications | postoperative complications | 90 days postoperative |
| clinically relevant postoperative fistula | clinically relevant postoperative fistula (2016 ISGPF definition) | 90 days postoperative |
| lenght of hospital stay | lenght of hospital stay | 90 days postoperative |
| readmission rate | readmission rate | 90 days postoperative |
| reoperation rate | reoperation rate | 90 days postoperative |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved
