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Not yet recruiting NCT06243887

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

No phase Interventional Esophageal Diseases Esophagostomy Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy, standard of care approaches in minimal invasive esophagectomy.
Who it may be relevant to
Registry conditions: Esophageal Diseases, Esophagostomy Complication. Basic parameters: 15 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other 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.
  • Other standard of care approaches in minimal invasive esophagectomy
    standard of care approaches other than ERAS

Primary outcome measures

  • Enhanced recovery after surgery (ERAS) [Time frame: average 2 years]
Secondary outcome measures (1)
  • Enhanced recovery after surgery (ERAS) [Time frame: average 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Puccetti F, Klevebro F, Kuppusamy M, Han S, Fagley RE, Low DE, Hubka M. Analysis of Compliance with Enhanced Recovery After Surgery (ERAS) Protocol for Esophagectomy. World J Surg. 2022 Dec;46(12):2839-2847. doi: 10.1007/s00268-022-06722-7. Epub 2022 Sep 22. PMID 36138318
  • Shen Y, Chen X, Hou J, Chen Y, Fang Y, Xue Z, D'Journo XB, Cerfolio RJ, Fernando HC, Fiorelli A, Brunelli A, Cang J, Tan L, Wang H; Written on behalf of the AME Thoracic Surgery Collaborative Group. The effect of enhanced recovery after minimally invasive esophagectomy: a randomized controlled trial. Surg Endosc. 2022 Dec;36(12):9113-9122. doi: 10.1007/s00464-022-09385-6. Epub 2022 Jun 30. PMID 35773604

Identifiers

NCT: NCT06243887 · Minimal invasive esophegectomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗