NCT05002855

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

August 4, 2021

Last Update Submit

September 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of the implementation of this protocol on 3-year overall survival.

    3-year overall survival rate

    3 years

Study Arms (2)

Enhanced Recovery After Surgery (ERAS)

Other: Enhanced Recovery After Surgery (ERAS)

Conventional Recovery Strategy (pre-ERAS)

Interventions

Multidisciplinary approach to perioperative care.

Enhanced Recovery After Surgery (ERAS)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients presenting or developing peritoneal cancer,
  • Patients having resection for palliative reasons,
  • Patients those under curatorship or tutelage
  • Opposed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean-Luc Faucheron

Grenoble, France

Location

Related Publications (8)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Officials

  • Jean-Luc Faucheron

    CHU Grenoble Alpes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

January 20, 2021

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations