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

NCT04305314 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 750

Last updated 2022-01-14

No results posted yet for this study

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).

Conditions

  • Major Surgery

Interventions

OTHER

PRI (Enhanced Recovery after surgery protocol)

Standard use of Spanish perioperative guidelines (PRI)

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto de Investigación Sanitaria Aragón

    collaborator OTHER

  • Grupo Español de Rehabilitación Multimodal

    lead OTHER

Principal Investigators

  • Jose M Ramirez, Prof. · Universidad de Zaragoza

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-09-30
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305314 on ClinicalTrials.gov