Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy (PREINSTRUCT)

Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy: a Retrospective Single-center Analysis

Minimally invasive distal pancreatectomy can be performed using either a laparoscopic or robotic approach. These minimally invasive techniques are becoming increasingly common in the surgical treatment of both benign and malignant pancreatic lesions. They offer several advantages over traditional open surgery, such as less postoperative pain, better cosmetic results, faster recovery, less blood loss during surgery, and lower healthcare costs. However, despite these advantages, evidence comparing postoperative outcomes, particularly complications, between laparoscopic and robotic distal pancreatectomy remains limited.

Previous studies suggest that robotic surgery may offer technical benefits, such as greater accuracy and precision, which could potentially result in fewer complications. However, the available literature is diverse and often based on small cohorts.

Study Overview

• Status: Completed
• Conditions: Distal Pancreatectomy (DP)

Detailed Description

Aim The aim of this study is to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.

Design A single center retrospective cohort study analysis of patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025.

Sample size All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025 were included in the study. This were 103 patients.

Study population

Inclusion and exclusion criteria:

All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025

Primary outcome To to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.

Secondary outcome measurements Secondary outcome measurements include the evaluation of the Comprehensive Complication Index (CCI), the conversion rates, length of hospital stays, readmission rates, mortality, and the number of lymph nodes harvested. Potential differences in medical costs will also be assessed.

Statistical analysis All data will be transferred from the platform into SPSS Version 28. For descriptive purposes, continuous data are shown as mean ± standard deviation (SD) or median (IQR) for nonnormally distributed data, and categorical data are presented as frequencies (%). For comparative analyses, the Chi-square or Fisher's exact test will be used for categorial variables, and the Independent t-test or Mann-Whitney U test for continuous variables. To assess the primary objective, a bivariate logistic regression model will be used. A P-value <0.05 was considered statistically significant.

Additional collected parameters that are not part of the mandatory registration for complex pancreatic surgery in Belgium are listed below:

- All relevant direct medical costs (e.g., consultation fees and medication) that arise from inpatient care provision will be collected using the financial records of the Jessa Hospital

Additional collected parameters are listed below and are collected as part of the mandatory registration for complex pancreatic surgery in Belgium in the Belgian Cancer Registry (BCR), specifically the "Complex Pancreatic Surgery" registration module:

• Administrative and demographic data
• Referral
• Clinical indication and diagnosis
• Diagnostic procedures
• Comorbidities
• Use of antithrombotic medication
• Neoadjuvant treatment
• Surgery details
• Postoperative outcomes
• Adjuvant therapy

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024 were included in the study.

Description

Inclusion Criteria:

• Underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024.

Exclusion Criteria:

• Underwent open procedure
• Restpancreatectomy
• Central pancreatectomy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day postoperative complications	Postoperative in-hospital complications in the 90-day postoperative period	90- days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative postoperative morbidity	Cumulative postoperative morbidity, quantified using the Comprehensive Complication Index (CCI), which integrates all complications weighted by severity	Patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
Length of hospital stay	Length of stay (days) starting from the moment of surgery	Time between start of surgery and discharge of hospital
Re-admissions	Re-admission within 30 days of discharge (from the center that performed the surgery)	within 30 days of discharge
Conversion rate	The rate at which planned minimally invasive surgeries (laparoscopic/robotic) are converted to open surgeries	Time from surgery until last follow up of the study
Mortality	Mortality up until 31/12/2025	Until the end of the study (31/12/2025)
Lymph nodes harvested	The number of lymph nodes that were retrieved during surgery	During surgery
Medical costs	Potential differences in medical costs will be assessed by means of a health-economic analysis.	From surgery until end of the study (31/12/2025)

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025/109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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