Effects of Incomplete ERAS on Clinical Outcomes in Patients With Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Effects of Incomplete Enhanced Recovery After Surgery Program on Long-term Survival of Patients Undergoing Colorectal Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412355
• Other study ID #: UHCT22040
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: June 2022
• Source: Wuhan Union Hospital, China
• Contact: Chenxing Jian, MD.
• Phone: 86-13959538950
• Email: ptyyjcx[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Enhanced recovery after surgery (ERAS) has been reported to be associated with improved outcomes in many studies, most of which involve short-term effects. Only a few studies have reported the long-term effects of highly compliant ERAS. However, to the best of our knowledge, there are no large-scale comparisons between incomplete ERAS (compliance < 70%) and non-ERAS. The aim of this comparative study is to analyze and evaluate the long-term outcomes of incomplete ERAS in laparoscopic colorectal cancer surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. age older than 18 years;2. pathological diagnosis of colorectal cancer;3. radical surgery was performed; and 4. laparoscopic surgery was performed.

Exclusion Criteria:

• 1. ERAS compliance =70%; 2. open surgery; 3. switch to laparotomy after laparoscopic surgery; 4. pregnancy or lactation; 5. severe mental illness; 6. Simultaneous malignant tumors of multiple organs; 7. History of other malignant tumors; and 8. Emergency radical colorectal resection due to obstruction, perforation or bleeding.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Enhanced Recovery After Surgery

Intervention

Procedure:
• ERAS protocol
ERAS protocol is a series of procedures that enhance the recovery of surgical patients. Patients were grouped according to whether the procedure was attempted.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.	Wuhan	Hubei
China	Union Hospital,Tongji Medical College, Huazhong University of Science and Technology.	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term survival	5-year Disease free survival and overall survival	Each patient will be followed for 5 years or until death
Secondary	Postoperative complications	Postoperative complications within 30 days after surgery.	within 30 days after surgery