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

Not Applicable

Not yet recruiting

• Conditions: Esophageal Diseases; Esophagostomy Complication
• Interventions: Other: standard of care approaches in minimal invasive esophagectomy; Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy

• Registration Number: NCT06243887
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Start: 2024-04-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	standard of care approaches in minimal invasive esophagectomy	patients of minimally invasive esophagectomy with standard of care approaches
ERAS group	Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy	patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol

Primary Outcome Measures

Name	Time	Method
Enhanced recovery after surgery (ERAS)	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

Secondary Outcome Measures

Name	Time	Method
Enhanced recovery after surgery (ERAS)	average 2 years	Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning; 1)postoperative chest drainage volume