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Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy

Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06243887
Enrollment
30
Registered
2024-02-06
Start date
2024-04-01
Completion date
2027-12-31
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Diseases, Esophagostomy Complication

Brief summary

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

Interventions

OTHEREnhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy

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.

OTHERstandard of care approaches in minimal invasive esophagectomy

standard of care approaches other than ERAS

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Enhanced recovery after surgery (ERAS)average 2 yearsDetect 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

Secondary

MeasureTime frameDescription
Enhanced recovery after surgery (ERAS)average 2 yearsDetect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning 1)postoperative chest drainage volume

Contacts

Primary ContactKhaled Hussein, master
khaledhassaan81@gmail.com+201098315303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026