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

Esophageal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243887
• Other study ID #: Minimal invasive esophegectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Khaled Hussein, master
• Phone: +201098315303
• Email: khaledhassaan81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhanced recovery after surgery (ERAS)	Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning; time to out-of-bed activity; time to first flatus; time to liquid diet; postoperative hospital stay; ICU length of stay; ICU length of stay; in-hospital mortality; incidence of various postoperative complications	average 2 years
Secondary	Enhanced recovery after surgery (ERAS)	Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning; 1)postoperative chest drainage volume	average 2 years