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Long-term Enlarged Survival After an Enhanced Recovery Protocol (LESAS). (LESAS)

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ClinicalTrials.gov Identifier: NCT04305314
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : January 14, 2022
Instituto de Salud Carlos III
Instituto de Investigación Sanitaria Aragón
Information provided by (Responsible Party):
Grupo Español de Rehabilitación Multimodal

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).

Condition or disease Intervention/treatment
Major Surgery Other: PRI (Enhanced Recovery after surgery protocol)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Surgical Treatment of Colorectal Cancer: Analysis of the Influence of an Enhanced Recovery Protocol on Long-term Oncological Outcomes.
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2025

Group/Cohort Intervention/treatment
Group 1: PRI > 70%
Compliance with the Enhanced Revovery protocol higher than 70%
Other: PRI (Enhanced Recovery after surgery protocol)
Standard use of Spanish perioperative guidelines (PRI)

Group 2: PRI < 70%
Compliance with the Enhanced Revovery protocol lower than 70%

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    patients alive from surgery to the last control

  2. Disease-free survival [ Time Frame: 5 years ]
    number of patients alive and without cancer recurrence from the intervention period until the end of follow-up

  3. Disease recurrence [ Time Frame: 5 years ]
    detected from the day of the intervention until the end of follow-up

Secondary Outcome Measures :
  1. Compliance of individual items of the protocol [ Time Frame: 5 years ]
    To evaluate the relationship between adherence to the protocol and 5-year survival

  2. Quality of Life (QOL) [ Time Frame: 5 years ]
    Quality of life according to the EuroQol (EQ-5D)

  3. Patient reported outcoms (PROs) [ Time Frame: 5 years ]
    According to EuroQol (EQ-5D) and self-completed disease-specific PROM questionnaire.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Inclusion Criteria:

  • All patients over 18 years of age who will be operated on a scheduled basis for colorectal cancer

Exclusion Criteria:

  • - Urgent surgery; -Existence of other concomitant surgical processes; -Patients diagnosed in stage IV cancer; -Patients who refuse to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305314

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Contact: Jose M Ramirez 639776364 jramirez@unizar.es

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Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain
Contact: José Luis Muñoz Rodés, PhD    +34 616 993 439    jlmunyoz@gmail.com   
Sub-Investigator: Eva Miranda         
Sub-Investigator: Luis Sanchez Guillen         
Sub-Investigator: Antonio Arroyo Sebastian         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain
Contact: Jose Antonio Garcia Erce, Phd    +34 670 807 552    jagarciaerce@gmail.com   
Principal Investigator: José Antonio García Erce, Prof         
Sub-Investigator: Miguel Salvador Bravo         
Sub-Investigator: Marta P Martín Vizcaíno         
Sub-Investigator: Francisco Javier Yoldi Murillo         
Sub-Investigator: Manuela Rubial Álvarez         
Sub-Investigator: Susana Hernández García         
Sub-Investigator: Fabiola Oteiza Martínez         
Principal Investigator: Enrique Balén Ribera         
Sub-Investigator: María Estrella Petrina Jauregui         
Sub-Investigator: Ana Zugasti Murillo         
Hospital de la Ribera Recruiting
Alzira, Spain
Contact: Javier Blanco    +34609 501 737    franciscojavierblancosurg@gmail.com   
Sub-Investigator: David Alvarez Martinez         
Hospital de Barbastro Recruiting
Barbastro, Spain
Contact: Estibaliz Echazarreta Gallego    +34690 336 742    esti.egallego@hotmail.com   
Sub-Investigator: Cristina Latre Saso         
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Spain
Contact: Ramón Rodríguez Fraile    +34618 733 979    jrrodriguezf@sescam.jccm.es   
Sub-Investigator: Mercedes Caballeros Olivares         
Sub-Investigator: Alba Manuel Vazquez         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain
Contact: Emilio Del Valle Hernández, Prof    +34646 489 439    emilio.valle@salud.madrid.org   
Principal Investigator: José Pérez Peña, PhD         
Sub-Investigator: Luis Miguel Jimenez Jimenez         
Hospital Jiménez Diaz Recruiting
Madrid, Spain
Contact: Miguel Leon Arellano    +34669 845 297    miguel.leon.arellano@gmail.com   
Sub-Investigator: Damian Garcia Olmo         
Sub-Investigator: Hector Guadalajara         
Hospital Universitario Infanta Leonor Recruiting
Madrid, Spain
Contact: Alfredo Abad Gurumeta, MD    649337762    alfredoabadgurumeta@gmail.com   
Sub-Investigator: Ane Abad Motos, MD         
Sub-Investigator: Javier Ripollés Melchor, PhD         
Sub-Investigator: Elena Sáez Ruiz, MD         
Sub-Investigator: Rut Salvachua, MD         
Sub-Investigator: Norma Aracil Escoda, MD         
Sub-Investigator: Beatriz Nozal Mateo, MD         
Complejo Asistencial Universitario de Palencia Recruiting
Palencia, Spain
Contact: Maria Eugenia Centeno Robles    +34675 332 770    meugeniacenteno@hotmail.com   
Sub-Investigator: Elisabeth Redondo         
Hospital General de Valencia Recruiting
Valencia, Spain
Contact: Carolina Martinez Perez    +34629 824 928    carolinamartinezperez@gmail.com   
Sub-Investigator: Elena Biosca Perez         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: José Manuel Ramírez Rodriguez, Prof    +34 639776364    jramirez@unizar.es   
Sub-Investigator: Manuela Elia Guedea         
Sub-Investigator: Elena Córdoba Díaz de Laspra         
Sub-Investigator: Tomás Ruiz Garcés         
Sub-Investigator: Javier Longás Valien         
Sub-Investigator: Julia Ocon Breton         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain
Contact: Javier Martínez Ubieto    +34630 505 151    jmtezubieto@hotmail.com   
Sub-Investigator: Ana Pascual Bellosta         
Sub-Investigator: Sonia Ortega Lucea         
Sponsors and Collaborators
Grupo Español de Rehabilitación Multimodal
Instituto de Salud Carlos III
Instituto de Investigación Sanitaria Aragón
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Principal Investigator: Jose M Ramirez, Prof. Universidad de Zaragoza
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Grupo Español de Rehabilitación Multimodal
ClinicalTrials.gov Identifier: NCT04305314    
Other Study ID Numbers: GERMFIS2020
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No