Registrar Performances in MIDP

Minimally Invasive Distal Pancreatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429074
• Other study ID #: RECHMPL20_0348
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Minimally Invasive Distal Pancreatectomy

Intervention

Procedure:
• Minimally invasive distal pancreatectomy
Minimally invasive distal pancreatectomy

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	open conversion rate	Necessity to swith from minimally invasive approach to open approach during laparoscopy	1 day
Secondary	Duration of surgery	Duration of surgery	1 day
Secondary	Intraoperative bloodloss	Intraoperative bloodloss	1 day
Secondary	Intraoperative transfusion	Intraoperative transfusion	1 day
Secondary	severe complications Clavien Dindo>3	severe complications Clavien Dindo>3	90 days postoperative
Secondary	postoperative complications	postoperative complications	90 days postoperative
Secondary	clinically relevant postoperative fistula	clinically relevant postoperative fistula (2016 ISGPF definition)	90 days postoperative
Secondary	lenght of hospital stay	lenght of hospital stay	90 days postoperative
Secondary	readmission rate	readmission rate	90 days postoperative
Secondary	reoperation rate	reoperation rate	90 days postoperative