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NCT05311787 Clinical Trial

The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

ERAS Clinical Trial

Official title:
The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery Based on Innovative Technologies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05311787
Other study ID # 315030310071
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date March 2026

Study information
Verified date April 2022
Source Vishnevsky Center of Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Application of the perioperative enhanced recovery protocol has allowed to carry out esophagectomy to the patients with severe comorbidities and has led reducing the risks of severe postoperative complications.

Description:

The clinical trial included the parients who participated in the protocol ERAS since 2011, who uderwent esophagectomy with simultaneous reconstruction. The parients had benign or malignant esophageal diseases. The ERAS protocol consisted of components of perioperative recovery. The number of patients until now has reached 400 patients. During trial there was modifications of aspects of ERAS protocol such as a rejection of nasogastric tube or cervical drenage. The role of multidisplinary team is the main success of the result of the implemented ERAS protocol.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 2026
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients with esophageal diseases Exclusion Criteria: - before 18 years old - who do not need surgery as a treatment - who not underwent simultaneous recontruction

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• esophagectomy with simultaneous reconstruction
Subtotal resection of esophagus and simultaneous reconstruction by gastric pull-up or colon conduit

Locations
Country Name City State
Russian Federation Mary Yan Moscow
Russian Federation Mary Yan Moscow

Sponsors (1)
Lead Sponsor Collaborator
Vishnevsky Center of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality the rate of mortality after surgery 30 days
Primary morbidity the rate of morbidity after surgery 30 days
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