Clinical trial · Observational
Long-term Enlarged Survival After an Enhanced Recovery Protocol (LESAS).
Surgical Treatment of Colorectal Cancer: Analysis of the Influence of an Enhanced Recovery Protocol on Long-term Oncological Outcomes.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Major Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRI (Enhanced Recovery after surgery protocol) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1: PRI > 70%
- description
- Compliance with the Enhanced Revovery protocol higher than 70%
- interventionNames
- Other: PRI (Enhanced Recovery after surgery protocol)
- label
- Group 2: PRI < 70%
- description
- Compliance with the Enhanced Revovery protocol lower than 70%
Primary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 5 years
- description
- patients alive from surgery to the last control
- measure
- Disease-free survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRamirez-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 33109675