Registrar Performances in MIDP

Completed

• Conditions: Minimally Invasive Distal Pancreatectomy
• Interventions: Procedure: Minimally invasive distal pancreatectomy

• Registration Number: NCT04429074
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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 Timeline

• Study Start: 2019-12-01
• Primary Completion: 2019-12-30
• Status Verified: 2020-06
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (Consultant)	Minimally invasive distal pancreatectomy	Group 2 (Consultant): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a consultant (expert)
Group 1 (Registrar)	Minimally invasive distal pancreatectomy	Group 1 (Registrar): Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology operated on by a registrar (young specialist surgeon)

Primary Outcome Measures

Name	Time	Method
open conversion rate	1 day	Necessity to swith from minimally invasive approach to open approach during laparoscopy

Secondary Outcome Measures

Name	Time	Method
readmission rate	90 days postoperative	readmission rate
Duration of surgery	1 day	Duration of surgery
Intraoperative bloodloss	1 day	Intraoperative bloodloss
lenght of hospital stay	90 days postoperative	lenght of hospital stay
reoperation rate	90 days postoperative	reoperation rate
Intraoperative transfusion	1 day	Intraoperative transfusion
severe complications Clavien Dindo>3	90 days postoperative	severe complications Clavien Dindo\>3
postoperative complications	90 days postoperative	postoperative complications
clinically relevant postoperative fistula	90 days postoperative	clinically relevant postoperative fistula (2016 ISGPF definition)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France