Actively Recruiting

Age: 18Years +
All Genders
ID05518643

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).

Led by University of Thessaly · Updated on 2025-04-22

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Thessaly

Lead Sponsor

I

IASO Thessalias

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how following the Enhanced Recovery After Surgery (ERAS) program affects patients undergoing pancreatic surgery. This observational study will track patient-reported outcomes, surgery-specific results, and the body's stress response after surgery. The study will include all patients having pancreatic surgery at two hospitals in Greece over three years, from 2022 to 2025. The goal is to understand how well patients recover, how complications develop, and how stress markers change with ERAS program adherence. Participants will follow the ERAS protocol before, during, and after their surgery. This includes patient education, nutritional support, smoking and alcohol advice, specific medication schedules, anesthesia techniques, early removal of tubes and drains, pain management, physical therapy, and diet progression. The protocol aims to support recovery through careful planning and monitoring. Data on patient characteristics, surgical details, complications, and adherence to ERAS steps will be collected throughout the study period. Participants will complete quality of life questionnaires before surgery, on day five after surgery, and at one week, one month, and six months after discharge. Blood tests measuring stress markers will be taken before surgery and during the first five days after. Researchers will track complications such as delayed gastric emptying, pancreatic fistula, and hemorrhage within six weeks, plus longer-term outcomes including hospital stay length, overall complications, and cancer recurrence. All data will be securely stored and analyzed to understand the impact of ERAS program compliance on recovery and outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients undergoing pancreatic surgery
  • Age 18 years or older
  • Fluent Greek speakers
  • No communication barriers
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Unable or unwilling to participate
  • Undergoing other surgical procedures
  • Communication barriers
  • Lost to follow-up

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Hospital stay up to approximately 6 weeks

Participants undergo pancreatic surgery following the ERAS protocol, including preoperative education and optimization, intraoperative care, and early postoperative management.

1 preoperative appointment and daily hospital visits through postoperative day 5

Post-operative Follow-up

Duration - Up to 6 weeks to 1 year after surgery

Participants are followed after hospital discharge to monitor recovery, complications, quality of life, and stress response.

Follow-up visits at 1 week post discharge, 1 month, 6 months, and ongoing monitoring up to 1 year

Trial Site Locations

Total: 1 location

1

University of Thessaly

Larissa, Greece, 45100

Actively Recruiting

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Research Team

D

Despoina Liotiri, Consultant

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019.

Emmanuel Melloul, Kristoffer Lassen, Didier Roulin...

https://pubmed.ncbi.nlm.nih.gov/32161987

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

N K Aaronson, S Ahmedzai, B Bergman...

https://pubmed.ncbi.nlm.nih.gov/8433390

Sample Size Guidelines for Logistic Regression from Observational Studies with Large Population: Emphasis on the Accuracy Between Statistics and Parameters Based on Real Life Clinical Data.

Mohamad Adam Bujang, Nadiah Sa'at, Tg Mohd Ikhwan Tg Abu Bakar Sidik...

https://pubmed.ncbi.nlm.nih.gov/30914854

Events per variable (EPV) and the relative performance of different strategies for estimating the out-of-sample validity of logistic regression models.

Peter C Austin, Ewout W Steyerberg

https://pubmed.ncbi.nlm.nih.gov/25411322