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

Jilin University

Status: Unknown

Conditions: Gastrostomy Complications

Treatments: Procedure: ERAS

Study type: Interventional

Funder types: Other

Identifiers

NCT03046303

ERAS for Radical gastrectomy

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

ERAS group

Experimental group

Description:

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

Treatment:

Procedure: ERAS

conventional pathway group

No Intervention group

Description:

The conventional pathway group received conventional care.