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OpenTrials
Completed

NCT Number: NCT04771832

ERAS in Gastrointerstinal Fistulas.

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.

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Key information

Conditions

Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery Site Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgery for gastrointestinal fistula

Exclusion criteria

  • conservative treatment

Treatment and study plan

ERAS

Procedure

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

Primary outcomes

  1. Postoperative complications

    Time frame: up to 24 weeks

    Any surgical complications

  2. length of hospital stay

    Time frame: up to 24 weeks

    duration of hospitalization

  3. postoperative nausea and vomiting

    Time frame: up to 24 weeks

    prevalence of postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2021
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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