Stool Collection Sub-Study of Exact Sciences Protocol 2018-01
NCT04473625
Cancer, Colo-rectal Cancer
Tucson, Arizona, United States
View Trial DetailsNCT Number: NCT07827378
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 48 hours after surgery
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
Contact information is provided by the study sponsor or research team.
Fundación para la Investigación del Hospital Clínico de Valencia
Other
RECUPERA-C Study: Protocol: Personalised and Controlled Rapid Recovery After Colorectal Surgery
Acronym: RECUPERA-C
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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