Fact CheckerSign in

NCT05518643Recruiting

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

Enhanced Recovery Program, Patient Reported Outcomes, Surgery-specific Outcomes and Stress Response After Pancreatic Surgery: A Prospective Observational Cohort Study by the Thessalic Pancreas Study Group (ThePANas).

Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
21 Aug 2022
Start date
15 Jul 2022
Primary completion date
May 2025
Lead sponsor
University of Thessaly
NCT number
NCT05518643

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 15 Jul 2022 to the primary completion date, May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • other surgical procedures

Age

  • younger than 18 years-old

Other

  • unable or unwilling to participate
  • communication barriers
  • lost to follow-up

Who the study is looking for

  • all pancreatic surgery patients
  • above the age of 18
  • fluent greek speakers
  • without communication barriers

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Thessaly
Coordinator of this site? Confirm its status
LarissaGreeceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.