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

N/ANot Yet RecruitingNCT06243887

Assiut University30 enrolled

Overview

Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Esophageal Diseases Esophagostomy Complication

Interventions

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Enhanced recovery after surgery (ERAS)

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

Time frame: average 2 years

Secondary Outcomes

Enhanced recovery after surgery (ERAS)

Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning 1)postoperative chest drainage volume

Time frame: average 2 years

Central Contacts

Khaled Hussein, master

CONTACT

+201098315303 khaledhassaan81@gmail.com

Data from ClinicalTrials.gov

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