Registrar Performances in MIDP

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.

Study Overview

• Status: Completed
• Conditions: Minimally Invasive Distal Pancreatectomy
• Intervention / Treatment: Procedure: Minimally invasive distal pancreatectomy

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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; 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; Minimally invasive distal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
open conversion rate	Necessity to swith from minimally invasive approach to open approach during laparoscopy	1 day

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: surgery; pancreas; laparoscopy; pancreatectomy; postoperative outcomes; Benign or borderline pathology (non-pancreatic cancer); registrar
• Other Study ID Numbers: RECHMPL20_0348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No