Enhanced Recovery After SurgeryERAS in CDUNCT04648644
Application of ERAS Protocol in Emergency Surgery
An observational study of Enhanced Recovery After Surgery and Emergency Surgery, run by University of Milano Bicocca at 8 sites in Italy.
Trial summary
This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enhanced Recovery After Surgery, Emergency Surgery
- What is being tested?
- Application of ERAS protocol
- How many people
- 589 participants
- Where
- 8 sitesItaly
- Study dates
- 3 Nov 2020to 30 Jun 2022
- How long will I take part?
- 30 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing emergency surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.
Who may be able to join
- patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.
Who cannot join
- age <18
- emergency surgery for post-operative complications of post diagnostic procedures
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Ospedale Manzoni
Lecco, LC
ASST Lodi
Lodi
Ospedale San Raffaele
Milan, Mi
ASST Monza
Monza, MB, 20900
Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello
Pisa
Ospedale San Jacopo
Pistoia
Policlinico Gemelli
Roma
Ospedale di Cattinara
Trieste
About this study
This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety
- Conditions
- Enhanced Recovery After Surgery, Emergency Surgery
- Being tested
- Application of ERAS protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of ERAS protocolOther
Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery
| Study group | Role | What they receive |
|---|---|---|
| Study population | All patients undergoing emergency abdominal surgery for infection or occlusion and treated with bowel resection with or without anastomosis; intestinal bypass or adhesiolysis Receives: Other: Application of ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: % of application of post-operative ERAS items
Compliance to the standardize protocol for each item
Measured: 30 days
Secondary outcomes (1)
Safety: complications rate within 30 days
Complication rate and mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start3 Nov 2020
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 589 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Braga, MD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648644
- Sponsor's protocol ID
- ERAS in CDU
- Acronym
- ERAS in CDU
- Status last verified
- Jul 2022
- First submitted
- 23 Nov 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of ERAS Protocol in Emergency Surgery
- ClinicalTrials.gov ID
- NCT04648644
- Acronym / sponsor ID
- ERAS in CDU / ERAS in CDU
- Conditions
- Enhanced Recovery After Surgery, Emergency Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 1 Dec 2020 (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.
This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Application of ERAS protocolAll patients undergoing emergency abdominal surgery for infection or occlusion and treated with bowel resection with or without anastomosis; intestinal bypass or adhesiolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing emergency surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.
Key inclusion criteria (1 listed)
- patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.
Key exclusion criteria (2 listed)
- age <18
- emergency surgery for post-operative complications of post diagnostic procedures
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 |
|---|---|---|
| Application of ERAS protocolApplication of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery | Other | Study population |
Primary outcome
Feasibility: % of application of post-operative ERAS items
Time frame: 30 days
Compliance to the standardize protocol for each item
1 secondary outcome
Safety: complications rate within 30 days
Time frame: 30 days
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 28 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Marco Braga, MD principal investigator
University of Milano Bicocca
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enhanced Recovery After Surgery and Emergency Surgery, run by University of Milano Bicocca at 8 sites in Italy.
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 2 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
Feasibility: % of application of post-operative ERAS items (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2022.