Esophageal DiseasesNCT06243887
Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy
A study testing Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy in people with Esophageal Diseases and Esophagostomy Complication, run by Assiut University.
Trial summary
Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery . Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Esophageal Diseases, Esophagostomy Complication
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for MIE; 3preoperative clinical stage of I to III
Who cannot join
- 1) patients had a history of thoracic or abdominal surgery; 2)patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .
Read the detailed description
esophagectomy for both malignant and benign disease has been identified as a particularly complex surgical procedure due to documented high levels of peri-operative morbidity and mortality.
A comprehensive review of complications associated with the esophagectomies performed in high-volume esophageal units utilizing a standardized format for documenting complications and quality measures has confirmed an overall complication rate of 59 % with 17.2% of patients sustaining complications of IIIb or greater utilizing the Clavien-Dindo severity grading system. post-operative complications include high rate of anastomotic leakage , pulmonary infection ,thoracic duct injury , voice changes , breathlessness ,long hospital stay.
These outcomes accentuate the need for providing an enhanced recovery after surgery standardized format for esophagectomy which can be routinely applied and audited to improve international outcomes. though ERAS lacking randomized control trials
- Conditions
- Esophageal Diseases, Esophagostomy Complication
- Being tested
- Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy, standard of care approaches in minimal invasive esophagectomy
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomyOther
Enhanced Recovery After Surgery (ERAS) refers to patient-centered, evidence-based, multidisciplinary team developed pathways for a surgical specialty and facility culture to reduce the patient's surgical stress response, optimize their physiologic function, and facilitate recovery.
standard of care approaches in minimal invasive esophagectomyOther
standard of care approaches other than ERAS
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Other | patients of minimally invasive esophagectomy with standard of care approaches Receives: Other: standard of care approaches in minimal invasive esophagectomy |
| ERAS group | Other | patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol Receives: Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced recovery after surgery (ERAS)
Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning
- time to out-of-bed activity
- time to first flatus
- time to liquid diet
- postoperative hospital stay
- ICU length of stay
- ICU length of stay
- in-hospital mortality
- incidence of various postoperative complications
Measured: average 2 years
Secondary outcomes (1)
Enhanced recovery after surgery (ERAS)
Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning
1)postoperative chest drainage volume
Measured: average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Hassaan Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243887
- Sponsor's protocol ID
- Minimal invasive esophegectomy
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Puccetti F, Klevebro F, Kuppusamy M, Han S, Fagley RE, Low DE, Hubka M. Analysis of Compliance with Enhanced Recovery After Surgery (ERAS) Protocol for Esophagectomy. World J Surg. 2022 Dec;46(12):2839-2847. doi: 10.1007/s00268-022-06722-7. Epub 2022 Sep 22.
PubMed 36138318Shen Y, Chen X, Hou J, Chen Y, Fang Y, Xue Z, D'Journo XB, Cerfolio RJ, Fernando HC, Fiorelli A, Brunelli A, Cang J, Tan L, Wang H; Written on behalf of the AME Thoracic Surgery Collaborative Group. The effect of enhanced recovery after minimally invasive esophagectomy: a randomized controlled trial. Surg Endosc. 2022 Dec;36(12):9113-9122. doi: 10.1007/s00464-022-09385-6. Epub 2022 Jun 30.
PubMed 35773604
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy
- ClinicalTrials.gov ID
- NCT06243887
- Acronym / sponsor ID
- Minimal invasive esophegectomy
- Conditions
- Esophageal Diseases, Esophagostomy Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2024 (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.
Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .
Detailed description
esophagectomy for both malignant and benign disease has been identified as a particularly complex surgical procedure due to documented high levels of peri-operative morbidity and mortality.
A comprehensive review of complications associated with the esophagectomies performed in high-volume esophageal units utilizing a standardized format for documenting complications and quality measures has confirmed an overall complication rate of 59 % with 17.2% of patients sustaining complications of IIIb or greater utilizing the Clavien-Dindo severity grading system. post-operative complications include high rate of anastomotic leakage , pulmonary infection ,thoracic duct injury , voice changes , breathlessness ,long hospital stay.
These outcomes accentuate the need for providing an enhanced recovery after surgery standardized format for esophagectomy which can be routinely applied and audited to improve international outcomes. though ERAS lacking randomized control trials
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Other | Other: standard of care approaches in minimal invasive esophagectomypatients of minimally invasive esophagectomy with standard of care approaches |
| ERAS group | Other | Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomypatients of minimally invasive esophagectomy with enhanced recovery after surgery protocol |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for MIE; 3preoperative clinical stage of I to III
Key exclusion criteria (1 listed)
- 1) patients had a history of thoracic or abdominal surgery; 2)patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data
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 After Surgery (ERAS) protocol in minimal invasive esophagectomyEnhanced Recovery After Surgery (ERAS) refers to patient-centered, evidence-based, multidisciplinary team developed pathways for a surgical specialty and facility culture to reduce the patient's surgical stress response, optimize their physiologic function, and facilitate recovery. | Other | ERAS group |
| standard of care approaches in minimal invasive esophagectomystandard of care approaches other than ERAS | Other | Conventional group |
Primary outcome
Enhanced recovery after surgery (ERAS)
Time frame: average 2 years
Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning 1. time to out-of-bed activity 2. time to first flatus 3. time to liquid diet 4. postoperative hospital stay 5. ICU length of stay 6. ICU length of stay 7. in-hospital mortality 8. incidence of various postoperative complications
1 secondary outcome
Enhanced recovery after surgery (ERAS)
Time frame: average 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 36138318Puccetti F, Klevebro F, Kuppusamy M, Han S, Fagley RE, Low DE, Hubka M. Analysis of Compliance with Enhanced Recovery After Surgery (ERAS) Protocol for Esophagectomy. World J Surg. 2022 Dec;46(12):2839-2847. doi: 10.1007/s00268-022-06722-7. Epub 2022 Sep 22.
- Background: PubMed 35773604Shen Y, Chen X, Hou J, Chen Y, Fang Y, Xue Z, D'Journo XB, Cerfolio RJ, Fernando HC, Fiorelli A, Brunelli A, Cang J, Tan L, Wang H; Written on behalf of the AME Thoracic Surgery Collaborative Group. The effect of enhanced recovery after minimally invasive esophagectomy: a randomized controlled trial. Surg Endosc. 2022 Dec;36(12):9113-9122. doi: 10.1007/s00464-022-09385-6. Epub 2022 Jun 30.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy in people with Esophageal Diseases and Esophagostomy Complication, run by Assiut University.
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: opening soon, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khaled Hussein, master (+201098315303, khaledhassaan81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced recovery after surgery (ERAS) (time frame: average 2 years). 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 NCT06243887, which also lists 2 linked publications.
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 22 Mar 2024.