- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002855
Effect of Implementation of Enhanced Recovery After Surgery on 3-year Survival After Colorectal Surgery for Cancer (RACCOR)
September 7, 2021 updated by: University Hospital, Grenoble
Effect of Implementation of Enhanced Recovery After Surgery (ERAS) Protocol on 3-year Survival After Colorectal Surgery for Cancer - a Retrospective Cohort of 1001 Patients
Several recent studies have shown that the Enhanced Recovery After Surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS).
The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1001
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
-
-
-
Grenoble, France
- Jean-Luc Faucheron
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population consisted of all consecutive adult patients, who had undergone resection for colorectal cancer or a precancerous lesion and were cared for using the ERAS protocol or received conventional care (pre-ERAS).
The records of consecutive patients recorded in the hospital's electronic medical records (PMSI) between January 2005 and December 2017 were screened.
Non-inclusion criteria included patients presenting or developing peritoneal cancer, patients having resection for palliative reasons, those under curatorship or tutelage.
Description
Inclusion Criteria:
- Aadult patients, who had undergone resection for colorectal cancer or a precancerous lesion and were cared for using the ERAS protocol or received conventional care (pre-ERAS).
- Informed patients
Exclusion Criteria:
- Patients presenting or developing peritoneal cancer,
- Patients having resection for palliative reasons,
- Patients those under curatorship or tutelage
- Opposed patients
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Enhanced Recovery After Surgery (ERAS)
|
Multidisciplinary approach to perioperative care.
|
|
Conventional Recovery Strategy (pre-ERAS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the effect of the implementation of this protocol on 3-year overall survival.
Time Frame: 3 years
|
3-year overall survival rate
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jean-Luc FAUCHERON, CHU Grenoble Alpes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alfonsi P, Slim K, Chauvin M, Mariani P, Faucheron JL, Fletcher D; le groupe de travail de la Societe francaise d'anesthesie et reanimation (Sfar) et de la Societe francaise de chirurgie digestive (SFCD). [Guidelines for enhanced recovery after elective colorectal surgery]. Ann Fr Anesth Reanim. 2014 May;33(5):370-84. doi: 10.1016/j.annfar.2014.03.007. Epub 2014 May 20. French.
- Gignoux B, Gosgnach M, Lanz T, Vulliez A, Blanchet MC, Frering V, Faucheron JL, Chasserant P. Short-term Outcomes of Ambulatory Colectomy for 157 Consecutive Patients. Ann Surg. 2019 Aug;270(2):317-321. doi: 10.1097/SLA.0000000000002800.
- Faucheron JL, Trilling B, Sage PY. Ambulatory colectomy: fast-track management pushed to its limits? Tech Coloproctol. 2018 Oct;22(10):741-742. doi: 10.1007/s10151-018-1871-5. Epub 2018 Nov 9. No abstract available.
- Trilling B, Sage PY, Faucheron JL. What is fast track multimodal management of colorectal cancer surgery in real life? Tech Coloproctol. 2018 May;22(5):401-402. doi: 10.1007/s10151-018-1799-9. Epub 2018 Jun 1. No abstract available.
- Carrier G, Cotte E, Beyer-Berjot L, Faucheron JL, Joris J, Slim K; Groupe Francophone de Rehabilitation Amelioree apres Chirurgie (GRACE). Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery. J Visc Surg. 2016 Aug;153(4):249-52. doi: 10.1016/j.jviscsurg.2016.05.016. Epub 2016 Aug 8.
- Slim K, Delaunay L, Joris J, Leonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de rehabilitation amelioree apres chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. No abstract available.
- Faujour V, Slim K, Corond P. [The future, in France, of enhanced recovery after surgery seen from the economical perspective]. Presse Med. 2015 Jan;44(1):e23-31. doi: 10.1016/j.lpm.2014.07.021. Epub 2014 Dec 22. French.
- Launay-Savary MV, Mathonnet M, Theissen A, Ostermann S, Raynaud-Simon A, Slim K; GRACE (Groupe francophone de Rehabilitation Amelioree apres Chirurgie). Are enhanced recovery programs in colorectal surgery feasible and useful in the elderly? A systematic review of the literature. J Visc Surg. 2017 Feb;154(1):29-35. doi: 10.1016/j.jviscsurg.2016.09.016. Epub 2016 Nov 11.
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)
January 20, 2021
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
August 4, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021
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.