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Recruiting NCT06935448

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

Observational Pancreatectomy Enhanced Recovery After Surgery Pancreatic Cancer Resectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: enhanced recovery after surgery.
Who it may be relevant to
Registry conditions: Pancreatectomy, Enhanced Recovery After Surgery, Pancreatic Cancer Resectable. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other enhanced recovery after surgery
    ERAS group follows the enhanced recovery after surgery program which involves 20 elements

Primary outcome measures

  • impact on length of stay [Time frame: within 30 days of surgery]
Secondary outcome measures (1)
  • impact on overall morbidity [Time frame: within 30 days from surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Greece · 1 center
  • University of Thessaly — Larissa

Publications

  • Cardini B, Primavesi F, Maglione M, et al. Outcomes following pancreatic resections-results and challenges of an Austrian university hospital compared to nationwide data and international centres. Eur Surg (2019) 51:81-89. https://doi.org/10.1007/s10353-019-0585-x
  • Lau CS, Chamberlain RS. Enhanced Recovery After Surgery Programs Improve Patient Outcomes and Recovery: A Meta-analysis. World J Surg. 2017 Apr;41(4):899-913. doi: 10.1007/s00268-016-3807-4. PMID 27822725

Identifiers

NCT: NCT06935448 · UNIVERSITY OF THESSALY 2412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗