ERAS in Gastrointerstinal Fistulas.

NCT ID: NCT04771832

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fistula Surgery Site Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ERAS

Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol

ERAS

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* surgery for gastrointestinal fistula

Exclusion Criteria

* conservative treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stanislaw Klek

Head of the Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stanislaw Klek, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanley Dudrick's Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

Klek S, Salowka J, Choruz R, Cegielny T, Welanyk J, Wilczek M, Szczepanek K, Pisarska-Adamczyk M, Pedziwiatr M. Enhanced Recovery after Surgery (ERAS) Protocol Is a Safe and Effective Approach in Patients with Gastrointestinal Fistulas Undergoing Reconstruction: Results from a Prospective Study. Nutrients. 2021 Jun 7;13(6):1953. doi: 10.3390/nu13061953.

Reference Type DERIVED
PMID: 34200140 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERASGI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PRP Use in Treatment of Fistula Ano
NCT04187651 ACTIVE_NOT_RECRUITING NA
Rectovaginal Fistula Repair
NCT05006586 COMPLETED
Tissue Therapy of Transsphincteric Anal Fistula
NCT06303752 RECRUITING PHASE1/PHASE2