Skip to main content
OpenTrials
Completed

NCT Number: NCT07338409

Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Distal Pancreatectomy (DP)

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Hospital

Hasselt, 3500, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 90-day postoperative complications

    Time frame: 90- days postoperative

    Postoperative in-hospital complications in the 90-day postoperative period

Secondary outcomes

  1. Cumulative postoperative morbidity

    Time frame: Patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025

    Cumulative postoperative morbidity, quantified using the Comprehensive Complication Index (CCI), which integrates all complications weighted by severity

  2. Length of hospital stay

    Time frame: Time between start of surgery and discharge of hospital

    Length of stay (days) starting from the moment of surgery

  3. Re-admissions

    Time frame: within 30 days of discharge

    Re-admission within 30 days of discharge (from the center that performed the surgery)

  4. Conversion rate

    Time frame: Time from surgery until last follow up of the study

    The rate at which planned minimally invasive surgeries (laparoscopic/robotic) are converted to open surgeries

  5. Mortality

    Time frame: Until the end of the study (31/12/2025)

    Mortality up until 31/12/2025

  6. Lymph nodes harvested

    Time frame: During surgery

    The number of lymph nodes that were retrieved during surgery

  7. Medical costs

    Time frame: From surgery until end of the study (31/12/2025)

    Potential differences in medical costs will be assessed by means of a health-economic analysis.

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

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

Acronym: PREINSTRUCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.