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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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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

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Esophageal Diseases Esophagostomy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Conventional group

patients of minimally invasive esophagectomy with standard of care approaches

Group Type OTHER

standard of care approaches in minimal invasive esophagectomy

Intervention Type OTHER

standard of care approaches other than ERAS

ERAS group

patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol

Group Type OTHER

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

Intervention Type OTHER

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.

Interventions

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Enhanced 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.

Intervention Type OTHER

standard of care approaches in minimal invasive esophagectomy

standard of care approaches other than ERAS

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No