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.
all pancreatic surgery patients
above the age of 18
fluent greek speakers
without communication barriers
younger than 18 years-old
unable or unwilling to participate
other surgical procedures
communication barriers
All consecutive community patients presented for pancreatic surgery
Cohort
Prospective
ERAS protocol
Procedure/SurgeryERAS protocol as described above
Change in patient-reported outcomes as measured by the Health Questionnaire EORTC QLQ-C30
This questionnaire assesses health related quality of life (HRQoL) for cancer patients and includes 30 questions. The QLQ-C30 includes five functional scales (physical, role, emotional, cognitive, and social functioning); eight symptom scales or single items (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, and diarrhea); an item to assess financial difficulties; 1 global health status scale; and 1 global quality of life scale. Each one of the first 28 items has 4 levels: 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much. The last 2 questions ask the patient to rate their own health and quality of life on a scale from 1 (very poor) to 7 (excellent). PROMs questionnaires will be distributed in paper format and filled out by pen.
Change on the stress response to surgery measured by the Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratio (NLR and PLR).
NLR and PLR will be calculated by blood tests
Rate of Delayed Gastric Emptying (DGE)
Number of DGE defined and graded according to the International Study Group of Pancreatic Surgery (ISGPS).
Rate of Post Pancreatic Fistula (POPF) formation
Number of POPF defined and graded according to the International Study Group of Pancreatic Fistula (ISGPF).
Length of hospital stay (LOS)
Total number of days spent in the hospital (including any readmission)
Overall morbidity rate
Number of any perioperative adverse events graded according to Clavien-Dindo
Cancer recurrence rate
Number of patients with cancer recurrence with metastases
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University of Thessaly
Lead sponsor
IASO Thessalias
Collaborator
Larissa University Hospital
Collaborator
