Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes
Recruiting · NCT05518643 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Thessaly
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- all pancreatic surgery patients
- above the age of 18
- fluent greek speakers
- without communication barriers
Exclusion criteria
- younger than 18 years-old
- unable or unwilling to participate
- other surgical procedures
- communication barriers
- lost to follow-up
Where it is running
1 location listed.
- University of Thessaly - Larissa, Greece