ERAS in Elderly Colorectal Cancer Surgery (STOMIS-ERAS)

January 7, 2025 updated by: Chang Gung Memorial Hospital

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?

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1392

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

From January 2018 to December 2022, comprehensive data on patients who underwent colorectal resection for malignancy at a single medical institute, Chang Gung Memorial Hospital, were prospectively collected and retrospectively reviewed.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
traditional care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of Hospital Stay and Time to First Passage of Flatus
Time Frame: 3 months
Measurement outcomes are the rate of post-operative recovery times, including postoperative stay(days) and first passage of flatus(days).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Actual)

December 5, 2024

Study Completion (Actual)

December 5, 2024

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202401646B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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