ClinicalTrials.gg
Status unknownNCT05311787Updated Apr 5, 2022

The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery

An interventional study of esophagectomy with simultaneous reconstruction in ERAS and Esophageal Diseases, sponsored by Vishnevsky Center of Surgery. Status unknown at 2 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Vishnevsky Center of Surgery · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 years 2 months after the study started (first participant enrolled Jan 2011, registered Mar 2022).

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ERAS
  • Esophageal Diseases

Browse trials for

03

In context

Esophageal Diseases

92 studies on the registry are indexed under Esophageal Diseases; 21 are open to participants now.

This study's planned enrollment of 500 is above the median of 50 across 66 interventional studies indexed under Esophageal Diseases.

Browse Esophageal Diseases studies →

Lead sponsor

Vishnevsky Center of Surgery is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients with esophageal diseases

Exclusion criteria

Exclusion Criteria:

  • before 18 years old
  • who do not need surgery as a treatment
  • who not underwent simultaneous recontruction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • 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

Interventions

  • Procedureesophagectomy with simultaneous reconstruction

    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

06

What researchers measure

Primary outcomes

  1. mortality

    the rate of mortality after surgery

    Time frame: 30 days

  2. morbidity

    the rate of morbidity after surgery

    Time frame: 30 days

07

Study locations

2 of 2 sites recruiting
  • Mary Yan
    Moscow, 117639, Russia
    Recruiting
    • Mary Yan, junior reseacher, MD · Contactyanmaria88@mail.ru · 89299521460
    • Dmitry Ruchkin, PhD · Principal investigator
    • Kovalerova Natalia, PhD · Sub investigator
    • Omelchenko George, MD · Sub investigator
    • Raevskaya Mariana, PhD · Sub investigator
    • Sizov Vadim, PhD · Sub investigator
    • Yan Mary, MD · Principal investigator
  • Mary Yan
    Moscow, 117639, Russia
    Recruiting
    • Mary Yan, MD · Contactyanmaria88@mail.ru · 89299521460
    • Dmitry Ruchkin, PhD · Principal investigator
    • Mary Yan, MD · Principal investigator
    • Kovalerova Natalia, PhD · Sub investigator
    • Omelchenko George, MD · Sub investigator
    • Raevskaya Marianna, PhD · Principal investigator
    • Sizov Vadim, PhD · Principal investigator
08

References and documents

Related links

Individual participant data

Plan to share: Yes — all IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: By the 2026, open access

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2011 to primary completion in Mar 2022, 134 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2022
First posted
Apr 5, 2022
StartActual
Jan 2011
Primary completionActual
Mar 2022
CompletionEst.
Mar 2026
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05311787
Lead sponsor
Vishnevsky Center of Surgery
Responsible party
Maria Yan (Principal Investigator, Vishnevsky Center of Surgery) — Principal investigator
First posted
Apr 5, 2022
Start date
Jan 2011
Primary completion
Mar 2022
Completion
Mar 2026 (estimated)
Last update
Apr 5, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion