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

NCT05412355 | Unknown

• 1 other identifier: UHCT22040
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Neoplasms; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• long-term survival

  5-year Disease free survival and overall survival

  Each patient will be followed for 5 years or until death

Secondary Outcomes (1)

• Postoperative complications

  within 30 days after surgery

Study Arms (2)

Incomplete ERAS

Incomplete ERAS was defined as ERAS compliance \< 70%.

Procedure: ERAS protocol

Non-ERAS

non-ERAS was defined as not executing any ERAS programs.

Procedure: ERAS protocol

Interventions

ERAS protocol PROCEDURE

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

Incomplete ERAS; Non-ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (2)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Wuhan, Hubei, 430000, China

RECRUITING

Union Hospital，Tongji Medical College, Huazhong University of Science and Technology.

Wuhan, Hubei, 430000, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Xiaogang Shu, MD.，PHD.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenxing Jian, MD.

CONTACT

86-13959538950; ptyyjcx@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: June 1, 2022
• Primary Completion: August 10, 2022
• Study Completion: October 10, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 2025.1.1
• Access Criteria: Approved by PI

Locations

CN (2)