FistulaNCT04771832
ERAS in Gastrointerstinal Fistulas.
An observational study of Fistula and Surgery Site Fistula, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistula, Surgery Site Fistula
- What is being tested?
- ERAS
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2011to 31 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: all patients scheduled for fistula surgery
Who may be able to join
- surgery for gastrointestinal fistula
Who cannot join
- conservative treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Fistula, Surgery Site Fistula
- Being tested
- ERAS
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol Receives: Procedure: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Any surgical complications
Measured: up to 24 weeks
length of hospital stay
duration of hospitalization
Measured: up to 24 weeks
postoperative nausea and vomiting
prevalence of postoperative nausea and vomiting
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2011
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, PhD, Principal investigator, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771832
- Sponsor's protocol ID
- ERASGI
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Publications
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.
PubMed 34200140
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04771832
- Acronym / sponsor ID
- ERASGI
- Conditions
- Fistula, Surgery Site Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAS | – | Procedure: ERASPerioperative care with Enhanced Recovery After Surgery (ERAS) protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients scheduled for fistula surgery
Key inclusion criteria (1 listed)
- surgery for gastrointestinal fistula
Key exclusion criteria (1 listed)
- conservative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERASEnhanced Recovery After Surgery (ERAS) protocol is an evidence-based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function | Procedure or surgery | ERAS |
Primary outcome
Postoperative complications
Time frame: up to 24 weeks
Any surgical complications
length of hospital stay
Time frame: up to 24 weeks
duration of hospitalization
postoperative nausea and vomiting
Time frame: up to 24 weeks
prevalence of postoperative nausea and vomiting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 34200140Klek 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.
- Individual participant dataSharing planned: No. No sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislaw Klek, PhD principal investigator
Stanley Dudrick's Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fistula and Surgery Site Fistula, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.