ERAS in Gastrointerstinal Fistulas.

• Sponsor: Stanley Dudrick's Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04771832
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 120
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fistula; Surgery Site Fistula	Procedure: ERAS

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [up to 24 weeks]

   Any surgical complications

2. length of hospital stay [up to 24 weeks]

   duration of hospitalization

3. postoperative nausea and vomiting [up to 24 weeks]

   prevalence of postoperative nausea and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• surgery for gastrointestinal fistula

Exclusion Criteria:

• conservative treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanley Dudrick's Memorial Hospital	Skawina		Poland	32-050

Sponsors and Collaborators

• Stanley Dudrick's Memorial Hospital

Investigators

• Principal Investigator: Stanislaw Klek, PhD, Stanley Dudrick's Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanislaw Klek, Head of the Unit, Stanley Dudrick's Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04771832
• Other Study ID Numbers: ERASGI
• First Posted: Feb 25, 2021
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fistula

Study Results

No Results Posted as of Feb 25, 2021