The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

April 2, 2022 updated by: Maria Yan, Vishnevsky Center of Surgery

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117639
        • Recruiting
        • Mary Yan
        • Principal Investigator:
          • Dmitry Ruchkin, PhD
        • Sub-Investigator:
          • Kovalerova Natalia, PhD
        • Sub-Investigator:
          • Omelchenko George, MD
        • Contact:
        • Principal Investigator:
          • Mary Yan, MD
        • Principal Investigator:
          • Raevskaya Marianna, PhD
        • Principal Investigator:
          • Sizov Vadim, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Early oral feeding
The part of our investigation was prostective randomised trial which compared the result of patients with early oral feeding (since first day) and traditional group (oral feeding since 5th day)
Procedure: esophagectomy with simultaneous reconstruction
Subtotal resection of esophagus and simultaneous reconstruction by gastric pull-up or colon conduit
Other Names:
  • esophagectomy with gastric pull-up
  • esophagectomy with colon conduit
  • McKeown
  • transhiatal esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
the rate of mortality after surgery
30 days
morbidity
Time Frame: 30 days
the rate of morbidity after surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vishnevsky Center of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2026

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 2, 2022

First Posted (ACTUAL)

April 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 2, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315030310071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD

IPD Sharing Time Frame

By the 2026, open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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