Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy

NCT ID: NCT06935448

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-05-30

Brief Summary

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This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program.

This pathway includes various interventions in the preoperative, intraoperative, and postoperative care of these patients, all aimed at enhancing their health status and postoperative results.

Detailed Description

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This prospective observational study is conducted by the same surgical team at two high-volume pancreatic cancer referral centers in Greece.

Patients undergoing elective pancreatic surgery are prospectively enrolled and managed according to a standardized ERAS protocol (ERAS group).

A control group, which received standard perioperative care before the implementation of ERAS, was retrospectively selected and matched based on demographic and clinical parameters.

The primary study endpoint is the length of hospital stay (LOS), while secondary endpoints include 30-day mortality and morbidity.

Conditions

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Pancreatectomy Enhanced Recovery After Surgery Pancreatic Cancer Resectable

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Control group

traditional perioperative care

No interventions assigned to this group

ERAS group

enhanced recovery after surgery perioperative care

enhanced recovery after surgery

Intervention Type OTHER

ERAS group follows the enhanced recovery after surgery program which involves 20 elements

Interventions

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enhanced recovery after surgery

ERAS group follows the enhanced recovery after surgery program which involves 20 elements

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adult patients
* diagnosis of pancreatic cancer
* elective open pancreatic surgery

Exclusion Criteria

* age \<18 years
* emergency pancreatic surgery
* other surgical procedures
* missing data
* lost to follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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DESPOINA LIOTIRI

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DESPOINA LIOTIRI, MD, DESAIC, EDRA, MSc, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

ATHINA SAMARA, MD, MSc, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

NIKOLAOS BEIS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

DIMITRIS ZACHAROULIS, PROFESSOR OF SURGERY

Role: STUDY_CHAIR

University of Thessaly

Alexandros Diamantis, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Locations

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University of Thessaly

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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DESPOINA LIOTIRI, MD MSc PhD(c)

Role: CONTACT

00302410996000

ATHINA SAMARA, MD MSc PhD(c)

Role: CONTACT

References

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Cardini B, Primavesi F, Maglione M, et al. Outcomes following pancreatic resections-results and challenges of an Austrian university hospital compared to nationwide data and international centres. Eur Surg (2019) 51:81-89. https://doi.org/10.1007/s10353-019-0585-x

Reference Type BACKGROUND

Lau CS, Chamberlain RS. Enhanced Recovery After Surgery Programs Improve Patient Outcomes and Recovery: A Meta-analysis. World J Surg. 2017 Apr;41(4):899-913. doi: 10.1007/s00268-016-3807-4.

Reference Type BACKGROUND
PMID: 27822725 (View on PubMed)

Related Links

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https://erassociety.org/guidelines/

ERAS society guidelines for pancreatic surgery

Other Identifiers

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UNIVERSITY OF THESSALY 2412

Identifier Type: -

Identifier Source: org_study_id

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