NCT05311787

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

11.2 years

First QC Date

March 22, 2022

Last Update Submit

April 2, 2022

Conditions

ERASEsophageal Diseases

Outcome Measures

Primary Outcomes (2)

  • mortality

    the rate of mortality after surgery

    30 days

  • morbidity

    the rate of morbidity after surgery

    30 days

Study Arms (1)

Early oral feeding

OTHER

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

Interventions

esophagectomy with simultaneous reconstructionPROCEDURE

Subtotal resection of esophagus and simultaneous reconstruction by gastric pull-up or colon conduit

Also known as: esophagectomy with gastric pull-up, esophagectomy with colon conduit, McKeown, transhiatal esophagectomy
Early oral feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with esophageal diseases

You may not qualify if:

  • before 18 years old
  • who do not need surgery as a treatment
  • who not underwent simultaneous recontruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mary Yan

Moscow, 117639, Russia

RECRUITING

Mary Yan

Moscow, 117639, Russia

RECRUITING

Related Links

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All the patients over 18 years old with esophageal diseases who are required surgical treatment include in trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 5, 2022

Study Start

January 1, 2011

Primary Completion

March 1, 2022

Study Completion

March 1, 2026

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

all IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
By the 2026, open access

Locations

RU(2)