Long-term Enlarged Survival After an Enhanced Recovery Protocol (LESAS).
LESAS
Surgical Treatment of Colorectal Cancer: Analysis of the Influence of an Enhanced Recovery Protocol on Long-term Oncological Outcomes.
1 other identifier
observational
750
1 country
12
Brief Summary
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondary objectives, we propose to analyze the weight of each of the predefined items in the oncological results as well as the quality of life. We design a multicentric prospective cohort study in people older than 18 years who are going to be operated on for colorectal cancer. 12 hospitals are being selected due to have a PRI implanted according to the RICA pathway published by the Spanish National Health Service. As stated by the literature, the intervention group will be formed for those hospitals with a minimum implementation level of 70% of the PRI and the control group will be the centers that do not reach this level of implementation. Compliance will be studied with 21 key performance indicators and results are analyzed with cancer survival indicators: Overall survival, cancer-specific survival and relapse-free survival). We will also study the time to recurrence, perioperative morbi-mortality, hospital stay and quality of life with the EQ-5D validated questionary. To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
12 active sites
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
First Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJanuary 14, 2022
January 1, 2022
2.1 years
March 10, 2020
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Overall Survival
patients alive from surgery to the last control
5 years
Disease-free survival
number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
5 years
Disease recurrence
detected from the day of the intervention until the end of follow-up
5 years
Secondary Outcomes (3)
Compliance of individual items of the protocol
5 years
Quality of Life (QOL)
5 years
Patient reported outcoms (PROs)
5 years
Study Arms (2)
Group 1: PRI > 70%
Compliance with the Enhanced Revovery protocol higher than 70%
Group 2: PRI < 70%
Compliance with the Enhanced Revovery protocol lower than 70%
Interventions
Standard use of Spanish perioperative guidelines (PRI)
Eligibility Criteria
Multicenter prospective observational cohort study in patients who meet inclusion criteria (18 years of age who will be operated on a scheduled basis for colorectal cancer ) in participating hospitals
You may qualify if:
- All patients over 18 years of age who will be operated on a scheduled basis for colorectal cancer
You may not qualify if:
- \- Urgent surgery; -Existence of other concomitant surgical processes; -Patients diagnosed in stage IV cancer; -Patients who refuse to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Hospital General Universitario de Elche
Elche, Alicante, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital de la Ribera
Alzira, Spain
Hospital de Barbastro
Barbastro, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Jiménez Diaz
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Complejo Asistencial Universitario de Palencia
Palencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Related Publications (1)
Ramirez-Rodriguez JM, Martinez-Ubieto J, Munoz-Rodes JL, Rodriguez-Fraile JR, Garcia-Erce JA, Blanco-Gonzalez J, Del Valle-Hernandez E, Abad-Gurumeta A, Centeno-Robles E, Martinez-Perez C, Leon-Arellano M, Echazarreta-Gallego E, Elia-Guedea M, Pascual-Bellosta A, Miranda-Tauler E, Manuel-Vazquez A, Balen-Rivera E, Alvarez-Martinez D, Perez-Pena J, Abad-Motos A, Redondo-Villahoz E, Biosta-Perez E, Guadalajara-Labajo H, Ripolles-Melchor J, Latre-Saso C, Cordoba-Diaz de Laspra E, Sanchez-Guillen L, Cabellos-Olivares M, Longas-Valien J, Ortega-Lucea S, Ocon-Breton J, Arroyo-Sebastian A, Garcia-Olmo D. Surgical treatment for colorectal cancer: analysis of the influence of an enhanced recovery programme on long-term oncological outcomes-a study protocol for a prospective, multicentre, observational cohort study. BMJ Open. 2020 Oct 27;10(10):e040316. doi: 10.1136/bmjopen-2020-040316.
PMID: 33109675DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jose M Ramirez, Prof.
Universidad de Zaragoza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 12, 2020
Study Start
September 1, 2020
Primary Completion
September 30, 2022
Study Completion
September 30, 2025
Last Updated
January 14, 2022
Record last verified: 2022-01