Radical Gastrectomy Within Enhanced Recovery Programs(ERA... | NCT03046303

Studies
Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial

NCT03046303

Sponsor

The First Hospital of Jilin University

Status

Unknown status

Last Update Posted

Feb 8, 2017Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Gastrostomy Complications

Interventions

ERAS

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

Feb 2017

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

Feb 20, 2017Estimated

Primary Completion Date

Mar 30, 2018Estimated

Completion Date

Jan 30, 2019Estimated

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Feb 5, 2017

First Posted Date

Feb 8, 2017Estimated

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

Feb 5, 2017

Last Update Posted Date

Feb 8, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ERAS group	Experimental	Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.	Procedure: ERAS
conventional pathway group	No Intervention	The conventional pathway group received conventional care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERAS	Procedure	optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization	ERAS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical parameters	length of post-operative stay	One week after operation

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complications	wound infection;post-opeartion bleeding;ileus;stenosis;leakage	30 days after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score < III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.

Exclusion Criteria:

patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Quan Wang, MD	Contact	+86-431-81875607		wangquan5607@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Hospital of Jilin University	Recruiting	Changchun	Jilin	130021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided