ERAS in Gastrointerstinal Fistulas.
Enhanced Recovery After Surgery (ERAS) Protocol is a Safe and Effective Approach in Patients With Gastrointestinal Fistulas Undergoing Reconstruction: Results From a Prospective Study.
1 other identifier
observational
100
1 country
1
Brief Summary
An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of ERAS protocol in surgical patients with ECF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFirst Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedFebruary 25, 2021
February 1, 2021
10 years
February 21, 2021
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Postoperative complications
Any surgical complications
up to 24 weeks
length of hospital stay
duration of hospitalization
up to 24 weeks
postoperative nausea and vomiting
prevalence of postoperative nausea and vomiting
up to 24 weeks
Study Arms (1)
ERAS
Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol
Interventions
Enhanced Recovery After Surgery (ERAS) protocol is an evidence-based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function
Eligibility Criteria
all patients scheduled for fistula surgery
You may qualify if:
- surgery for gastrointestinal fistula
You may not qualify if:
- conservative treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanley Dudrick's Memorial Hospital
Skawina, 32-050, Poland
Related Publications (1)
Klek S, Salowka J, Choruz R, Cegielny T, Welanyk J, Wilczek M, Szczepanek K, Pisarska-Adamczyk M, Pedziwiatr M. Enhanced Recovery after Surgery (ERAS) Protocol Is a Safe and Effective Approach in Patients with Gastrointestinal Fistulas Undergoing Reconstruction: Results from a Prospective Study. Nutrients. 2021 Jun 7;13(6):1953. doi: 10.3390/nu13061953.
PMID: 34200140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stanislaw Klek, PhD
Stanley Dudrick's Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Unit
Study Record Dates
First Submitted
February 21, 2021
First Posted
February 25, 2021
Study Start
January 1, 2011
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
No sharing