ERAS in Gastrointerstinal Fistulas.

Completed

• Conditions: Fistula; Surgery Site Fistula
• Interventions: Procedure: ERAS

• Registration Number: NCT04771832
• Lead Sponsor: Stanley Dudrick's Memorial Hospital

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.

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 Timeline

• Study Start: 2011-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-25
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• surgery for gastrointestinal fistula

Exclusion Criteria

• conservative treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS	ERAS	Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol

Primary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	up to 24 weeks	prevalence of postoperative nausea and vomiting
Postoperative complications	up to 24 weeks	Any surgical complications
length of hospital stay	up to 24 weeks	duration of hospitalization

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland