ERAS Protocol, EsophagectomyNCT05856253
Enhanced Recovery in Esophageal Surgery
An observational study of ERAS Protocol, Esophagectomy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Esophageal surgery remains the main treatment for esophageal cancer. Despite constant improvements, morbidity of esophagectomy remains high. For several years, enhanced rehabilitation programs have been used to reduce the impact of surgery on the patients to support a faster recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ERAS Protocol, Esophagectomy
- What is being tested?
- Enhanced recovery program
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2019to 30 Nov 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients operated on esophagectomy for malignant and non malignant esophageal pathologies.
Who may be able to join
- All consecutive esophagectomy
Who cannot join
- Contraindication for surgery according to the WHO physical status of IV, emergency surgery, mental illness and patient's refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Early Results on an Enhanced Recovery Program in Esophageal Surgery
Esophageal surgery remains the main treatment for esophageal cancer. Despite constant improvements, morbidity of esophagectomy remains high. For several years, enhanced rehabilitation programs have been used to reduce the impact of surgery on the patients to support a faster recovery. This study analyses the first results of newly implemented enhanced program after esophagectomy within the framework of an academic center.
- Conditions
- ERAS Protocol, Esophagectomy
- Being tested
- Enhanced recovery program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery programProcedure or surgery
Recvoery programs includes specific measures validated in multidisciplinary consultation, spread over the pre- intra- and postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Not described Receives: Procedure: Enhanced recovery program | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who reach the the 23 measurements of the enhanced recovery program
compliance is defined by the achievement of the various items of the rehabilitation program (23 items)
Measured: an average of 15 days (During the surgical period (hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jun 2019
- Primary completion1 Jun 2019
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERAS Protocol, EsophagectomyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deswysen Yannick, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856253
- Sponsor's protocol ID
- 2023/23Jan/038
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Early Results on an Enhanced Recovery Program in Esophageal Surgery
- ClinicalTrials.gov ID
- NCT05856253
- Acronym / sponsor ID
- 2023/23Jan/038
- Conditions
- ERAS Protocol, Esophagectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 12 May 2023 (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.
Esophageal surgery remains the main treatment for esophageal cancer. Despite constant improvements, morbidity of esophagectomy remains high. For several years, enhanced rehabilitation programs have been used to reduce the impact of surgery on the patients to support a faster recovery. This study analyses the first results of newly implemented enhanced program after esophagectomy within the framework of an academic center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Procedure: Enhanced recovery program |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on esophagectomy for malignant and non malignant esophageal pathologies.
Key inclusion criteria (1 listed)
- All consecutive esophagectomy
Key exclusion criteria (1 listed)
- Contraindication for surgery according to the WHO physical status of IV, emergency surgery, mental illness and patient's refusal.
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 |
|---|---|---|
| Enhanced recovery programRecvoery programs includes specific measures validated in multidisciplinary consultation, spread over the pre- intra- and postoperative period. | Procedure or surgery | ERAS group |
Primary outcome
Number of participants who reach the the 23 measurements of the enhanced recovery program
Time frame: an average of 15 days (During the surgical period (hospital stay)
compliance is defined by the achievement of the various items of the rehabilitation program (23 items)
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 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for ERAS Protocol, Esophagectomy
Not yet recruiting
Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy
Esophageal Diseases, Esophagostomy Complication
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ERAS Protocol, Esophagectomy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 12 May 2023. 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 Belgium. 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?
Number of participants who reach the the 23 measurements of the enhanced recovery program (time frame: an average of 15 days (During the surgical period (hospital stay)). 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 12 May 2023.