NCT05518643 Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes
| NCT ID | NCT05518643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Thessaly |
| Condition | ERAS |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-07-15 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Despoina Liotiri, Consultant
PRINCIPAL INVESTIGATOR
University of Thessaly, IASO Thessalias
Frequently Asked Questions
Who can join the NCT05518643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ERAS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05518643 currently recruiting?
Yes, NCT05518643 is actively recruiting participants. Contact the research team at deppieliotiri@gmail.com for enrollment information.
Where is the NCT05518643 trial being conducted?
This trial is being conducted at Larissa, Greece.
Who is sponsoring the NCT05518643 clinical trial?
NCT05518643 is sponsored by University of Thessaly. The principal investigator is Despoina Liotiri, Consultant at University of Thessaly, IASO Thessalias. The trial plans to enroll 120 participants.