ERAS in Gastrointerstinal Fistulas.

Fistula Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771832
• Other study ID #: ERASGI
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• surgery for gastrointestinal fistula

Exclusion Criteria:

• conservative treatment

Related Conditions & MeSH terms

• Fistula
• Surgery Site Fistula

Intervention

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

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Any surgical complications	up to 24 weeks
Primary	length of hospital stay	duration of hospitalization	up to 24 weeks
Primary	postoperative nausea and vomiting	prevalence of postoperative nausea and vomiting	up to 24 weeks