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

Assiut University

Status: Not yet enrolling

Conditions: Esophagostomy Complication; Esophageal Diseases

Treatments: Other: standard of care approaches in minimal invasive esophagectomy; Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06243887

Minimal invasive esophegectomy

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Conventional group

Other group

Description:

patients of minimally invasive esophagectomy with standard of care approaches

Treatment:

Other: standard of care approaches in minimal invasive esophagectomy

ERAS group

Other group

Description:

patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol

Treatment:

Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy