NCT05856253

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

Same day

First QC Date

April 7, 2023

Last Update Submit

May 3, 2023

Conditions

ERAS Protocol, Esophagectomy

Outcome Measures

Primary Outcomes (1)

  • Number of participants who reach the the 23 measurements of the enhanced recovery program

    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)

Study Arms (2)

ERAS group

Procedure: Enhanced recovery program

Control group

Interventions

Enhanced recovery programPROCEDURE

Recvoery programs includes specific measures validated in multidisciplinary consultation, spread over the pre- intra- and postoperative period.

ERAS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All consecutive esophagectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique Associé

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 12, 2023

Study Start

June 1, 2019

Primary Completion

June 1, 2019

Study Completion

November 30, 2021

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)