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Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes

NCT05518643 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-04-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of compliance with enhanced recovery after surgery (ERAS) program on patient reported outcomes (PROs), surgery-specific outcomes and stress response after pancreatic surgery.

This prospective observational study will include all consecutive patients undergoing pancreatic surgery over a period of three years (2022 - 2025) at two sites, namely University General Hospital of Larissa and IASO Thessalias, in Greece. Patients will be prospectively enrolled after written informed consent. Data will be collected on patient characteristics, surgical and anaesthetic techniques, complications, and length of stay. Quality of life questionnaires will be administered to patients preoperatively, on the fith postoperative day, first follow-up after discharge, one month and six months after the operation. The stress response will be assessed by measuring the Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio (NLR and PLR) preoperatively, and on the first five postoperative days. Data will be collected on pancreatic surgery-specific complications such as delayed gastric emptying (DGE), post-pancreatectomy haemorrhage (PPH) and postoperative pancreatic fistula (POPF) formation. Anonymised data will be uploaded by the principal investigator on a protected excel spreadsheet for analysis.

Conditions

  • ERAS
  • Pancreas Cancer
  • Pancreas; Fistula
  • Delayed Gastric Emptying
  • Surgery-Complications
  • Pancreatic Hemorrhage
  • PROMs

Interventions

PROCEDURE

ERAS protocol

ERAS protocol as described above

Sponsors & Collaborators

  • IASO Thessalias

    collaborator OTHER

  • Larissa University Hospital

    collaborator OTHER

  • University of Thessaly

    lead OTHER

Principal Investigators

  • Despoina Liotiri, Consultant · University of Thessaly, IASO Thessalias

  • Dimitrios Zacharoulis, Professor · University of Thessaly

  • Eleni Arnaoutoglou, Professor · University of Thessaly

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05518643 on ClinicalTrials.gov