Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy

April 16, 2025 updated by: DESPOINA LIOTIRI, University of Thessaly

Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy; Experience From Two Referral Centers in Central Greece.

This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program.

This pathway includes various interventions in the preoperative, intraoperative, and postoperative care of these patients, all aimed at enhancing their health status and postoperative results.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective observational study is conducted by the same surgical team at two high-volume pancreatic cancer referral centers in Greece.

Patients undergoing elective pancreatic surgery are prospectively enrolled and managed according to a standardized ERAS protocol (ERAS group).

A control group, which received standard perioperative care before the implementation of ERAS, was retrospectively selected and matched based on demographic and clinical parameters.

The primary study endpoint is the length of hospital stay (LOS), while secondary endpoints include 30-day mortality and morbidity.

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Larissa, Greece
        • Recruiting
        • University of Thessaly

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing pancreatic surgery in two pancreatic cancer referral centers in central Greece, namely the University Hospital of Larissa, and IASO Thessalias general hospital

Description

Inclusion Criteria:

  • adult patients
  • diagnosis of pancreatic cancer
  • elective open pancreatic surgery

Exclusion Criteria:

  • age <18 years
  • emergency pancreatic surgery
  • other surgical procedures
  • missing data
  • lost to follow-up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
traditional perioperative care
ERAS group
enhanced recovery after surgery perioperative care
Other: enhanced recovery after surgery
ERAS group follows the enhanced recovery after surgery program which involves 20 elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact on length of stay
Time Frame: within 30 days of surgery
total number of days spent in the hospital including any readmission
within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact on overall morbidity
Time Frame: within 30 days from surgery
number of any perioperative adverse events
within 30 days from surgery

Collaborators and Investigators

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

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c), University of Thessaly
  • Principal Investigator: ATHINA SAMARA, MD, MSc, PhD(c), University of Thessaly
  • Principal Investigator: NIKOLAOS BEIS, MD, University of Thessaly
  • Study Chair: DIMITRIS ZACHAROULIS, PROFESSOR OF SURGERY, University of Thessaly
  • Principal Investigator: Alexandros Diamantis, MD, MSc, PhD, University of Thessaly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 1, 2019

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVERSITY OF THESSALY 2412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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