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

January 5, 2026 updated by: Stessel Björn, Jessa Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
90-day postoperative complications
Time Frame: 90- days postoperative
Postoperative in-hospital complications in the 90-day postoperative period
90- days postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
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
Time between start of surgery and discharge of hospital
Re-admissions
Time Frame: within 30 days of discharge
Re-admission within 30 days of discharge (from the center that performed the surgery)
within 30 days of discharge
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
Time from surgery until last follow up of the study
Mortality
Time Frame: Until the end of the study (31/12/2025)
Mortality up until 31/12/2025
Until the end of the study (31/12/2025)
Lymph nodes harvested
Time Frame: During surgery
The number of lymph nodes that were retrieved during surgery
During surgery
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.
From surgery until end of the study (31/12/2025)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jessa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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