Clinical Trial

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

Recruiting
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Record status
This record was last updated April 22, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-08-24; most recent amendment 2025-04-16.
Trial Details
NCT Number NCT05518643
Lead Sponsor University of Thessaly
Collaborators: IASO Thessalias, Larissa University Hospital
Conditions ERAS, Pancreas Cancer, Pancreas; Fistula, Delayed Gastric Emptying, Surgery-Complications, Pancreatic Hemorrhage, PROMs
Enrollment 120 participants
Start Date 2022-07-15
Primary Completion 2025-05 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2025-04-22