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

February 5, 2017 updated by: The First Hospital of Jilin University

Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.
Procedure: ERAS
optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization
No Intervention: conventional pathway group
The conventional pathway group received conventional care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2017

Primary Completion (Anticipated)

March 30, 2018

Study Completion (Anticipated)

January 30, 2019

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 5, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ERAS for Radical gastrectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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