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CHASE : aCcelerated 23-Hour erAS Care for Colorectal Surgery

NCT04461275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-03-02

No results posted yet for this study

Summary

Rationale: Throughout the years, there has been a rapid change in the perioperative protocols and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes was seen. Nowadays, researchers focus on further improving the current standard ERAS programs enabling an accelerated version hereof.

Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after surgery.

Study design: This study is an investigator-initiated, single-center prospective study.

Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal pathology that meet the eligibility criteria will be invited to participate in this study.

Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol, patients receiving elective colorectal surgery will be discharged 23-hours after surgery.

Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success rate will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in percentage of patients who were not able to be discharged 23 hours after surgery.

Conditions

Interventions

OTHER

ERAS 2.0

ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • James van Bastelaar, M.D., PhD · GE-, Oncologic-surgeon

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-08-30
Completion
2021-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461275 on ClinicalTrials.gov