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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Boramae Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center |
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The goal of this study is to implement and investigate the efficacy of an Early Recovery After Surgery (ERAS) protocol in South Korean colorectal cancer patients.
The primary outcome will be the postoperative time taken to achieve the 'discharge criteria'.
Secondary outcomes will include adherence, hospital stay, early complications, mortality, pain scores, re-admission and quality of life questionnaire scores.
As a single arm study, all participants will be treated according to an ERAS protocol, which includes components such as early ambulation, minimal fasting, multimodal pain control and omission of- or early removal of invasive catheters.
This multi-center prospective single arm clinical trial aims to investigate each component and item in the ERAS protocol implemented to perioperative care of colorectal cancer patients.
The primary endpoint will be the 'postoperative time to discharge criteria'. Discharge criteria will be defined as meeting all the criteria below:
Secondary outcomes will include:
The specific ERAS protocol to be used in this study has been developed by Seoul National University Hospital, benchmarking the 2018 ERAS® society guidelines for colorectal surgery. The implementation process has been helped and guided by the ERAS® Implementation Program of the Encare team.
The ERAS protocol includes:
This study aims to establish evidence on the factors affecting adherence and efficacy of each ERAS category, to guide a future pivotal RCT that will aim to develop a personalized, risk-stratified ERAS protocol that considers surgical risk and patient factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERAS implemented arm | Experimental | ERAS protocol implemented patients (single arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Procedure | The ERAS protocol includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative time to discharge criteria | The time (days) from initiation of surgery to achieving the discharge criteria. Discharge criteria is defined as meeting all of the following criteria:
| From the date of surgery until the date of first achieving all of the discharge criteria, assessed up to 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the ERAS protocol | Adherence to each item in the ERAS protocol | From date of enrollment to the date of discharge after surgery, assessed up to 100 days |
| Hospital stay | Total length of hospital stay for surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Yong Jeong, M.D., Ph.D. | Seoul National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
| National Cancer Center, Korea | OTHER_GOV |
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| From the date of hospital admission until the date of discharge after surgery, assessed up to 100 days |
| Early postoperative complication | Postoperative complication within 30 days of surgery. | From the day of surgery to the 30th postoperative day |
| Postoperative mortality | Death caused by the surgery itself or any complication related to surgery. | From day of surgery until the end of clinical data gathering, assessed upto 100 days. |
| Postoperative pain score: the Numeric Rating Scale (NRS) | Postoperative pain, evaluated using the Numeric Rating Scale (NRS) scale. This scale ranges from 0 to 10, with increasing values representing more severe pain. 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain Pain scores at rest, and pain scores at movement will be collected and analyzed separately. | From day of surgery until the end of clinical data gathering, assessed upto 100 days. |
| Re-admission within 30 days | Re-admission due to surgery complication within 30 days of surgery. | From randomization until the end of clinical data gathering, assessed upto 100 days. |
| Health-related Quality of Life | Health related quality of life, assessed using the 5-level EQ-5D version (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | From randomization until the end of clinical data gathering, assessed upto 100 days. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |