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

Not Applicable

• Conditions: Gastrostomy Complications
• Interventions: Procedure: ERAS

• Registration Number: NCT03046303
• Lead Sponsor: The First Hospital of Jilin University

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 available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-05
• Last Update Submitted: 2017-02-05
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08
• Study Start: 2017-02-20
• Primary Completion: 2018-03-30
• Study Completion: 2019-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
clinical parameters	One week after operation	length of post-operative stay

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after operation	wound infection;post-opeartion bleeding;ileus;stenosis;leakage

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China