Enhanced Recovery in Esophageal Surgery

May 3, 2023 updated by: Deswysen Yannick, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Implementation and Early Results on an Enhanced Recovery Program in Esophageal Surgery

Esophageal surgery remains the main treatment for esophageal cancer. Despite constant improvements, morbidity of esophagectomy remains high. For several years, enhanced rehabilitation programs have been used to reduce the impact of surgery on the patients to support a faster recovery. This study analyses the first results of newly implemented enhanced program after esophagectomy within the framework of an academic center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients operated on esophagectomy for malignant and non malignant esophageal pathologies.

Description

Inclusion Criteria:

  • All consecutive esophagectomy

Exclusion Criteria:

  • Contraindication for surgery according to the WHO physical status of IV, emergency surgery, mental illness and patient's refusal.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
ERAS group
Procedure: Enhanced recovery program
Recvoery programs includes specific measures validated in multidisciplinary consultation, spread over the pre- intra- and postoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who reach the the 23 measurements of the enhanced recovery program
Time Frame: an average of 15 days (During the surgical period (hospital stay)
compliance is defined by the achievement of the various items of the rehabilitation program (23 items)
an average of 15 days (During the surgical period (hospital stay)

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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)

June 1, 2019

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/23Jan/038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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