NCT04305314 (LESAS) is a clinical trial of PRI (Enhanced Recovery after surgery protocol) in Major Surgery, sponsored by Grupo Español de Rehabilitación Multimodal.

Who is sponsoring NCT04305314?

NCT04305314 is sponsored by Grupo Español de Rehabilitación Multimodal.

What drugs are being tested in NCT04305314?

Interventions in NCT04305314: PRI (Enhanced Recovery after surgery protocol).

What condition does NCT04305314 study?

NCT04305314 studies Major Surgery.

Is NCT04305314 still recruiting?

NCT04305314 is currently status unknown. Last updated 14 January 2022.

Last reviewed 2022-01-14 · How we verify

NCT04305314: LESAS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Last updated 14 January 2022

What this trial tests

trial testing PRI (Enhanced Recovery after surgery protocol) in Major Surgery in 750 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
30 September 2022

30 September 2025

Quick facts

Lead sponsor	Grupo Español de Rehabilitación Multimodal
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	750
Start date	1 September 2020
Primary completion	30 September 2022
Estimated completion	30 September 2025
Sites	12 locations across Spain

Drugs / interventions tested

PRI (Enhanced Recovery after surgery protocol)

Conditions studied

Major Surgery — all drugs for Major Surgery →

Sponsor

Grupo Español de Rehabilitación Multimodal — full company profile →

Who can join

18 and older, any sex, with Major Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Ramirez-Rodriguez JM, Martinez-Ubieto J, Muñoz-Rodes JL, Rodriguez-Fraile JR, et al · · 2020 · cited 8× · PMID 33109675 · DOI 10.1136/bmjopen-2020-040316

Verify or expand the search:

Other recruiting trials for Major Surgery

Currently open trials in the same condition.

NCT06774274 — Analgesic Efficacy of Intravenous Ketamine as a Continuous Infusion vs PCA in the Management of Acute Postoperative Pain · Phase 4 · recruiting
NCT04461301 — Multimodal Prehabilitation for Surgery in the Elderly: a Randomised, Prospective, Multicenter, Multidisciplinary Trial · NA · recruiting

Other Grupo Español de Rehabilitación Multimodal trials

Trials by the same sponsor.

NCT06790238 — POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery (POWER 4 + · active not recruiting
NCT06369194 — POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol · active not recruiting
NCT04799379 — Microporous Polysaccharide Hemospheres (MPH) Improving Outcome After Rectal Surgery · completed
NCT03864861 — Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol · unknown
NCT03865810 — Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04305314 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grupo Español de Rehabilitación Multimodal
Last refreshed: 14 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04305314.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing