Early Discharge After Colorectal Surgery (RECUPERA-C)
14. september 2026 opdateret af: Fundación para la Investigación del Hospital Clínico de Valencia
RECUPERA-C Study: Protocol: Personalised and Controlled Rapid Recovery After Colorectal Surgery
RECUPERA-C is a prospective observational pilot study evaluating the feasibility and safety of an early discharge strategy within 48 hours after minimally invasive colorectal surgery.
The study will assess whether patients can meet predefined clinical and functional discharge criteria, and will identify factors that may prevent early discharge.
C-reactive protein and neutrophil-to-lymphocyte ratio will also be evaluated as exploratory markers of postoperative complications.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
RECUPERA-C is a prospective observational cohort study conducted within an established Enhanced Recovery After Surgery (ERAS) program. The study will include adult patients undergoing elective major colorectal surgery through a minimally invasive approach.
The study will evaluate a structured early discharge protocol based on predefined clinical and functional criteria. Patients will be assessed during the first 48 hours after surgery to determine whether they meet the conditions considered necessary for safe discharge. These criteria include clinical stability, adequate pain and nausea control, oral intake, gastrointestinal recovery, and functional recovery.
Patients will be followed prospectively for 30 days after surgery. The study will evaluate the proportion of patients meeting the early discharge criteria, the actual early discharge rate, reasons for prolonged hospitalisation, total length of stay, postoperative complications, readmissions, healthcare resource utilisation, and patient satisfaction.
C-reactive protein and neutrophil-to-lymphocyte ratio will be collected as exploratory biomarkers to assess their potential association with postoperative complications and their possible role as complementary tools for risk stratification.
The study will also identify clinical, functional, social, and organisational factors that may limit implementation of the early discharge strategy. The overall aim is to determine whether a structured discharge pathway within an ERAS programme can safely and feasibly reduce hospital stay to 48 hours or less after minimally invasive colorectal surgery.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
97
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Julieta Puente-Monserrat, MD
- Telefonnummer: +34628370371
- E-mail: juliethpuente27@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will consist of adult patients undergoing elective major minimally invasive colorectal surgery at the participating centre.
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Elective major colorectal surgery for benign or malignant disease.
- Minimally invasive approach (laparoscopic or robotic).
- ASA physical status I-III.
- Functional independence in basic activities of daily living.
- Adequate home support and the ability to access and return to the hospital if required.
- Adequate understanding of the perioperative plan.
- Written informed consent.
Exclusion Criteria:
- Emergency surgery.
- Significant intraoperative complications.
- Major multivisceral resections.
- New ostomy creation.
- Functional dependence or significant cognitive impairment.
- Decompensation of major comorbidities.
- Anticipated need for postoperative admission to an intensive care unit.
- Social circumstances that may make early discharge unsafe.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Colorectal Surgery Patients
Adult patients undergoing elective major minimally invasive colorectal surgery.
A structured early discharge pathway (≤48 hours) will be applied based on predefined clinical and functional criteria.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
Tidsramme: Within 48 hours after surgery
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Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
|
Within 48 hours after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. doi: 10.1016/j.ijsu.2006.05.013. Epub 2006 Jun 27.
- Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.
- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.
- Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM; COlon cancer Laparoscopic or Open Resection Study Group (COLOR). Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol. 2005 Jul;6(7):477-84. doi: 10.1016/S1470-2045(05)70221-7.
- Alsharqawi N, Alhashemi M, Kaneva P, Baldini G, Fiore JF Jr, Feldman LS, Lee L. Validity of the I-FEED score for postoperative gastrointestinal function in patients undergoing colorectal surgery. Surg Endosc. 2020 May;34(5):2219-2226. doi: 10.1007/s00464-019-07011-6. Epub 2019 Jul 30.
- Pajaron-Guerrero M, Fernandez-Miera MF, Duenas-Puebla JC, Cagigas-Fernandez C, Allende-Mancisidor I, Cristobal-Poch L, Gomez-Fleitas M, Manzano-Peral MA, Gonzalez-Fernandez CR, Aguilera-Zubizarreta A, Sanroma-Mendizabal P; Hospital Valdecilla ERAS Study Group. Early Discharge Programme on Hospital-at-Home Evaluation for Patients with Immediate Postoperative Course after Laparoscopic Colorectal Surgery. Eur Surg Res. 2017;58(5-6):263-273. doi: 10.1159/000479004. Epub 2017 Aug 9.
- van Outersterp L, Laurijs SHH, Amraoui YE, Peeters AE, Verdaasdonk EEG. Monitoring early discharge after laparoscopic colon surgery: an interventional study. Surg Endosc. 2025 Jun;39(6):3654-3661. doi: 10.1007/s00464-025-11716-2. Epub 2025 Apr 29.
- Leenen JPL, Ardesch V, Patijn G. Remote Home Monitoring of Continuous Vital Sign Measurements by Wearables in Patients Discharged After Colorectal Surgery: Observational Feasibility Study. JMIR Perioper Med. 2023 May 5;6:e45113. doi: 10.2196/45113.
- Dos Santos BDN, Beruti C, Azevedo J, Herrando I, Vieira P, Domingos H, Heald R, Fernandez L, Parvaiz A. Using inflammatory parameters for safe and early discharge after minimally invasive colorectal surgery for colorectal cancer. Tech Coloproctol. 2025 Apr 7;29(1):97. doi: 10.1007/s10151-025-03134-2.
- Adamina M, Warschkow R, Naf F, Hummel B, Rduch T, Lange J, Steffen T. Monitoring c-reactive protein after laparoscopic colorectal surgery excludes infectious complications and allows for safe and early discharge. Surg Endosc. 2014 Oct;28(10):2939-48. doi: 10.1007/s00464-014-3556-0. Epub 2014 May 23.
- Warschkow R, Beutner U, Steffen T, Muller SA, Schmied BM, Guller U, Tarantino I. Safe and early discharge after colorectal surgery due to C-reactive protein: a diagnostic meta-analysis of 1832 patients. Ann Surg. 2012 Aug;256(2):245-50. doi: 10.1097/SLA.0b013e31825b60f0.
- Buscail E, Duchalais E. Unplanned re-hospitalizations after colorectal surgery. J Visc Surg. 2025 Aug;162(4S):S39-S45. doi: 10.1016/j.jviscsurg.2025.06.009. Epub 2025 Aug 5.
- McLemore EC, Lee L, Hedrick TL, Rashidi L, Askenasy EP, Popowich D, Sylla P. Same day discharge following elective, minimally invasive, colorectal surgery : A review of enhanced recovery protocols and early outcomes by the SAGES Colorectal Surgical Committee with recommendations regarding patient selection, remote monitoring, and successful implementation. Surg Endosc. 2022 Nov;36(11):7898-7914. doi: 10.1007/s00464-022-09606-y. Epub 2022 Sep 21.
- Yu ZH, Wang LM, Chan LY, You JF, Lin GP. Accelerated enhanced recovery after colorectal surgery with early discharge: A systematic review and meta-analysis. Langenbecks Arch Surg. 2026 Feb 27;411(1):104. doi: 10.1007/s00423-026-03977-9.
- Tavernier C, Flaris AN, Passot G, Glehen O, Kepenekian V, Cotte E. Assessing Criteria for a Safe Early Discharge After Laparoscopic Colorectal Surgery. JAMA Surg. 2022 Jan 1;157(1):52-58. doi: 10.1001/jamasurg.2021.5551.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Faktiske)
1. september 2026
Studieafslutning (Anslået)
30. september 2027
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RECUPERA-C
- 2025/431 (Anden identifikator: Comité de Ética de la Investigación con medicamentos (CEIm) del Hospital Clínico Universitario de Valencia)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No plan to share individual participant data (IPD).
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