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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06243887
Other study ID # Minimal invasive esophegectomy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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