Enhanced Recovery in Esophageal Surgery
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT05856253
Collaborator
(none)
40
1
30
1.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Implementation and Early Results on an Enhanced Recovery Program in Esophageal Surgery
Actual Study Start Date
:
Jun 1, 2019
Actual Primary Completion Date
:
Jun 1, 2019
Actual Study Completion Date
:
Nov 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ERAS group
|
Procedure: Enhanced recovery program
Recvoery programs includes specific measures validated in multidisciplinary consultation, spread over the pre- intra- and postoperative period.
|
| Control group
|
Outcome Measures
Primary Outcome Measures
- Number of participants who reach the the 23 measurements of the enhanced recovery program [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)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques universitaires Saint-Luc | Brussels | Belgium | 1200 |
Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Deswysen Yannick,
Chef de Clinique Associé,
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT05856253
Other Study ID Numbers:
- 2023/23Jan/038
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No