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The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

Primary Purpose

ERAS, Esophageal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
esophagectomy with simultaneous reconstruction
Sponsored by
Vishnevsky Center of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ERAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mary YanRecruiting
  • Mary YanRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Early oral feeding

Arm Description

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)

Outcomes

Primary Outcome Measures

mortality
the rate of mortality after surgery
morbidity
the rate of morbidity after surgery

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
April 2, 2022
Sponsor
Vishnevsky Center of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05311787
Brief Title
The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery
Official Title
The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery Based on Innovative Technologies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2011 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vishnevsky Center of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Esophageal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All the patients over 18 years old with esophageal diseases who are required surgical treatment include in trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early oral feeding
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
esophagectomy with simultaneous reconstruction
Other Intervention Name(s)
esophagectomy with gastric pull-up, esophagectomy with colon conduit, McKeown, transhiatal esophagectomy
Intervention Description
Subtotal resection of esophagus and simultaneous reconstruction by gastric pull-up or colon conduit
Primary Outcome Measure Information:
Title
mortality
Description
the rate of mortality after surgery
Time Frame
30 days
Title
morbidity
Description
the rate of morbidity after surgery
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mary Yan
City
Moscow
ZIP/Postal Code
117639
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Yan, junior reseacher, MD
Phone
89299521460
Email
yanmaria88@mail.ru
First Name & Middle Initial & Last Name & Degree
Dmitry Ruchkin, PhD
First Name & Middle Initial & Last Name & Degree
Kovalerova Natalia, PhD
First Name & Middle Initial & Last Name & Degree
Omelchenko George, MD
First Name & Middle Initial & Last Name & Degree
Raevskaya Mariana, PhD
First Name & Middle Initial & Last Name & Degree
Sizov Vadim, PhD
First Name & Middle Initial & Last Name & Degree
Yan Mary, MD
Facility Name
Mary Yan
City
Moscow
ZIP/Postal Code
117639
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Yan, MD
Phone
89299521460
Email
yanmaria88@mail.ru
First Name & Middle Initial & Last Name & Degree
Dmitry Ruchkin, PhD
First Name & Middle Initial & Last Name & Degree
Mary Yan, MD
First Name & Middle Initial & Last Name & Degree
Kovalerova Natalia, PhD
First Name & Middle Initial & Last Name & Degree
Omelchenko George, MD
First Name & Middle Initial & Last Name & Degree
Raevskaya Marianna, PhD
First Name & Middle Initial & Last Name & Degree
Sizov Vadim, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD
IPD Sharing Time Frame
By the 2026, open access
Links:
URL
https://intensive-care.ru/rannee-peroralnoe-pitanie-kak-komponent-programmy-uskorennogo-vosstanovleniya-posle-subtotalnoj-ezofagektomii-s-odnomomentnoj-plastikoj-pishhevoda-prospektivnoe-randomizirovannoe-issledovanie/
Description
Related Info

Learn more about this trial

The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

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