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

NCT ID: NCT03046303

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2019-01-30

Brief Summary

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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

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Conditions

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Gastrostomy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ERAS group

Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.

Group Type EXPERIMENTAL

ERAS

Intervention Type PROCEDURE

optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization

conventional pathway group

The conventional pathway group received conventional care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ERAS

optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Quan Wang, MD

Role: CONTACT

+86-431-81875607

Facility Contacts

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Quan Wang, MD

Role: primary

+86-431-81875607

Other Identifiers

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ERAS for Radical gastrectomy

Identifier Type: -

Identifier Source: org_study_id

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