Minimally Invasive Distal PancreatectomyNCT04429074
Registrar Performances in MIDP
An observational study of Minimally Invasive Distal Pancreatectomy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Minimally Invasive Distal Pancreatectomy
- What is being tested?
- Minimally invasive distal pancreatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology
Who may be able to join
- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology between 2009-2020
Who cannot join
- open distal pancreatectomy
- minimally invasive distal pancreatectomy for pancreatic cancer
- 20 first consecutive patients operated on by the consultant (learning curve)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes
This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.
Read the detailed description
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
- Minimally Invasive Distal Pancreatectomy
- Being tested
- Minimally invasive distal pancreatectomy
- Keywords
- Benign or borderline pathology (non-pancreatic cancer), laparoscopy, registrar, postoperative outcomes, pancreatectomy, surgery, pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive distal pancreatectomyProcedure or surgery
Minimally invasive distal pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Minimally invasive distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
open conversion rate
Necessity to swith from minimally invasive approach to open approach during laparoscopy
Measured: 1 day
Secondary outcomes (9)
Duration of surgery
Duration of surgery
Measured: 1 day
Intraoperative bloodloss
Intraoperative bloodloss
Measured: 1 day
Intraoperative transfusion
Intraoperative transfusion
Measured: 1 day
severe complications Clavien Dindo>3
severe complications Clavien Dindo>3
Measured: 90 days postoperative
postoperative complications
postoperative complications
Measured: 90 days postoperative
clinically relevant postoperative fistula
clinically relevant postoperative fistula (2016 ISGPF definition)
Measured: 90 days postoperative
lenght of hospital stay
lenght of hospital stay
Measured: 90 days postoperative
readmission rate
readmission rate
Measured: 90 days postoperative
reoperation rate
reoperation rate
Measured: 90 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Dec 2019
- Primary completion30 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Distal PancreatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- REGIS SOUCHE, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429074
- Sponsor's protocol ID
- RECHMPL20_0348
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT04429074
- Acronym / sponsor ID
- RECHMPL20_0348
- Conditions
- Minimally Invasive Distal Pancreatectomy
- Keywords
- Benign or borderline pathology (non-pancreatic cancer), laparoscopy, registrar, postoperative outcomes, pancreatectomy, surgery, pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Registrar) | – | Procedure: Minimally invasive distal pancreatectomyGroup 1 (Registrar): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a registrar (young specialist surgeon) |
| Group 2 (Consultant) | – | Procedure: Minimally invasive distal pancreatectomyGroup 2 (Consultant): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a consultant (expert) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology
Key inclusion criteria (1 listed)
- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology between 2009-2020
Key exclusion criteria (3 listed)
- open distal pancreatectomy
- minimally invasive distal pancreatectomy for pancreatic cancer
- 20 first consecutive patients operated on by the consultant (learning curve)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive distal pancreatectomyMinimally invasive distal pancreatectomy | Procedure or surgery | Group 1 (Registrar), Group 2 (Consultant) |
Primary outcome
open conversion rate
Time frame: 1 day
Necessity to swith from minimally invasive approach to open approach during laparoscopy
9 secondary outcomes
Duration of surgery
Time frame: 1 day
Intraoperative bloodloss
Time frame: 1 day
Intraoperative transfusion
Time frame: 1 day
severe complications Clavien Dindo>3
Time frame: 90 days postoperative
postoperative complications
Time frame: 90 days postoperative
clinically relevant postoperative fistula
Time frame: 90 days postoperative
lenght of hospital stay
Time frame: 90 days postoperative
readmission rate
Time frame: 90 days postoperative
reoperation rate
Time frame: 90 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Minimally Invasive Distal Pancreatectomy
Recruiting
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Pancreatectomy, Distal Pancreatectomy (DP)
Not yet recruiting
Comparison of Kimura Versus Warshaw Technique for Laparoscopic Spleen-Preserving Distal Pancreatectomy
Pancreatic Tumor, Benign, Pancreatic Neuroendocrine Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
REGIS SOUCHE study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Distal Pancreatectomy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
open conversion rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.