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Clinical Trials/NCT06764888
NCT06764888
Completed
Not Applicable

Short-Term Outcomes of Minimally Invasive Surgery in Elderly Colorectal Cancer Patients in the Era of ERAS: is a "One-Size-Fits-All" Strategy Sufficient?

Chang Gung Memorial Hospital1 site in 1 country1,392 target enrollmentJune 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ERAS
Sponsor
Chang Gung Memorial Hospital
Enrollment
1392
Locations
1
Primary Endpoint
Short-term postoperative complications rate.
Status
Completed
Last Updated
last year

Overview

Brief Summary

Enhanced recovery protocol consisted of a series of elements aiming to optimize and standardize perioperative care. This study aims to evaluate the safety and feasibility of a modified ERAS protocol following colorectal surgery in the elderly population, aged 65 years or older. This is a retrospective study based on prospectively collected data. Patient privacy has been carefully protected throughout the research process, and no aspect of this study interfered with or altered the patients' treatment or clinical care.

Registry
clinicaltrials.gov
Start Date
June 5, 2024
End Date
December 5, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • they underwent radical resection for colorectal cancer
  • the procedure was minimally invasive surgery
  • they were aged 65 or older
  • they provided signed informed consent.

Exclusion Criteria

  • Patients who underwent emergency surgery for colorectal cancer.
  • Patients with incomplete medical records or missing data relevant to the study.
  • Patients with synchronous malignancies or a history of other cancers within the past five years.
  • Patients with severe comorbidities (e.g., advanced cardiovascular, respiratory, or renal diseases) that contraindicate ERAS protocol implementation.
  • Patients with preoperative metastatic disease or locally advanced tumors requiring palliative procedures.
  • Patients who did not comply with or complete the ERAS protocol during the perioperative period.

Outcomes

Primary Outcomes

Short-term postoperative complications rate.

Time Frame: 3 months

Measurement outcomes included the rate of short-term postoperative complications, overall morbidity, early morbidity, reoperation rate, 30-day readmission rates and 30-day mortality rates. Postoperative complications were carefully recorded and classified using the Clavien-Dindo classification system for a standardised severity evaluation. These complications are critical for assessing surgical outcomes and ensuring patient safety. Early complications were defined as those occurring during the initial hospitalisation or within 30 days of surgery, while late complications were defined as those arising after the patient's discharge from the hospital.

Secondary Outcomes

  • Days of Hospital Stay and Time to First Passage of Flatus(3 months)

Study Sites (1)

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