Compliance to ERAS After Gastric Surgery | NCT01653496

Studies
Compliance to ERAS After Gastric Surgery

NCT01653496

Sponsor

Chonnam National University Hospital

Status

Completed

Last Update Posted

Feb 2, 2016Estimated

Enrollment

168Actual

Phase

Phase 2

Conditions

Stomach Neoplasms

Interventions

Enhanced recovery after surgery

Countries

South Korea

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 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 13, 2012

First Submission Date that Met QC Criteria

Jul 27, 2012

First Posted Date

Jul 31, 2012Estimated

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 1, 2016

Last Update Posted Date

Feb 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young Kyu Park, Professor, Department of Gastroenterologic Surgery, Chonnam National University HospitalPrincipal Investigator

Lead Sponsor

Chonnam National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.

Detailed Description

The feasibility and effectiveness of ERAS program for various major surgical procedures have been well studies in the literature. However, ERAS program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. In this study, we developed ERAS program for gastric cancer surgery, based on the systemic review about perioperative cares. The main elements of ERAS program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria.

The aim of study is to evaluate the compliance to these main elements of ERAS program in patients undergoing gastric cancer surgery.

Previously reported data about ERAS program for colon surgery reported overall compliance as about 65%. Considering that this is a single center study, we expected overall compliance rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enhanced recovery after surgery	Experimental	Patients who receive ERAS program after gastric cancer surgery	Procedure: Enhanced recovery after surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhanced recovery after surgery	Procedure	The main 18 elements of ERAS program included are described in detail in the brief summary of the study	Enhanced recovery after surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall compliance to the ERAS program	Patient's compliance to the 18 main elements of ERAS program	90 days

Secondary Outcomes

Measure	Description	Time Frame
Morbidity	Postoperative complications means any complications occured within 90 days after operation, and will be assessed based on the predefined definition and severity of postoperative complication of our institution.	90 days
Hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are to undergo gastric cancer surgery
ASA score < 3
ECOG performance status 0-1
Adequate hepatic, renal, and hematologic function
Written informed consent

Exclusion Criteria:

Previous abdominal operation history
Concommitant other organ malignant disease
Preoperative chemotherapy or radiation therapy
Concommitant other organ resection during surgery
Emergency operation due to bleeding or perforation
Active underlying medical illness
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-Kyu Park, MD, PhD	Chonnam National University Hospital, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam Nationl University Hwasun Hospital		Hwasun-gun	Jeollanam-do	519-809	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29789971	Derived	Jung MR, Ryu SY, Park YK, Jeong O. Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study. Ann Surg Oncol. 2018 Aug;25(8):2366-2373. doi: 10.1245/s10434-018-6524-4. Epub 2018 May 22.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D019990	Perioperative Care
D013514	Surgical Procedures, Operative