Effects of Incomplete ERAS on Clinical Outcomes in Patien... | NCT05412355

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

NCT05412355

Sponsor

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

Status

Unknown status

Last Update Posted

Jun 24, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Colorectal Neoplasms
Enhanced Recovery After Surgery

Interventions

ERAS protocol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Aug 10, 2022Estimated

Completion Date

Oct 10, 2022Estimated

First Submitted Date

Jun 6, 2022

First Submission Date that Met QC Criteria

Jun 6, 2022

First Posted Date

Jun 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2022

Last Update Posted Date

Jun 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaogang Shu, Prof., Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chenxing Jian, MD.	Contact	86-13959538950		ptyyjcx@126.com

Overall Officials

Name	Affiliation	Role
Xiaogang Shu, MD.，PHD.	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.	Recruiting	Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

After the funders finished the study,the data will be available，if approved by PI.

Types

Study Protocol

Time Frame

After 2025.1.1

Access Criteria

Approved by PI

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided