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

• Conditions: Colorectal Neoplasms; Enhanced Recovery After Surgery
• Interventions: Procedure: ERAS protocol

• Registration Number: NCT05412355
• Lead Sponsor: Wuhan Union Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-24
• Primary Completion: 2022-08-10
• Study Completion: 2022-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incomplete ERAS	ERAS protocol	Incomplete ERAS was defined as ERAS compliance \< 70%.
Non-ERAS	ERAS protocol	non-ERAS was defined as not executing any ERAS programs.

Primary Outcome Measures

Name	Time	Method
long-term survival	Each patient will be followed for 5 years or until death	5-year Disease free survival and overall survival

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	within 30 days after surgery	Postoperative complications within 30 days after surgery.

Trial Locations

Locations (2)

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, China