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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Neoplasms; Enhanced Recovery After Surgery
• Intervention / Treatment: Procedure: ERAS protocol

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Chenxing Jian, MD.; Phone Number: 86-13959538950; Email: ptyyjcx@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
      • Contact: Xiaogang Shu; Phone Number: +8613959538950; Email: sxg678@yahoo.com
    • Wuhan, Hubei, China, 430000
      • Active, not recruiting
      • Union Hospital，Tongji Medical College, Huazhong University of Science and Technology.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this study, we are going to collect clinical data of patients undergoing laparoscopic radical surgery from four large hospitals between August 2008 and December 2016.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incomplete ERAS; Incomplete ERAS was defined as ERAS compliance < 70%.	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.
Non-ERAS; non-ERAS was defined as not executing any ERAS programs.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term survival	5-year Disease free survival and overall survival	Each patient will be followed for 5 years or until death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications within 30 days after surgery.	within 30 days after surgery

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Xiaogang Shu, MD.，PHD., Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2022
• Primary Completion (ANTICIPATED): August 10, 2022
• Study Completion (ANTICIPATED): October 10, 2022

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: UHCT22040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the funders finished the study,the data will be available，if approved by PI.
• IPD Sharing Time Frame: After 2025.1.1
• IPD Sharing Access Criteria: Approved by PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No