ERAS in Gastrointerstinal Fistulas.

February 23, 2021 updated by: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Enhanced Recovery After Surgery (ERAS) Protocol is a Safe and Effective Approach in Patients With Gastrointestinal Fistulas Undergoing Reconstruction: Results From a Prospective Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 F, 56 M, mean age 54.1) was evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Skawina, Poland, 32-050
        • Stanley Dudrick's Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients scheduled for fistula surgery

Description

Inclusion Criteria:

  • surgery for gastrointestinal fistula

Exclusion Criteria:

  • conservative treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERAS
Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol
Procedure: ERAS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: up to 24 weeks
Any surgical complications
up to 24 weeks
length of hospital stay
Time Frame: up to 24 weeks
duration of hospitalization
up to 24 weeks
postoperative nausea and vomiting
Time Frame: up to 24 weeks
prevalence of postoperative nausea and vomiting
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanley Dudrick's Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERASGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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