Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status

Not Applicable

• Conditions: Nutrition Disorders
• Interventions: Procedure: perioperational nutrition surpport

• Registration Number: NCT03043183
• 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.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06
• Study Start: 2017-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• 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;
• age 18-75 years;
• pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
• normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease;
• no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
• PG-SGA score ≥2，<9

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
Preoperational nutrition support group	perioperational nutrition surpport	Scored patient-generated subjective global assessment(PG-SGA) ≥2，\<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation

Primary Outcome Measures

Name	Time	Method
complication	30 days after operation	fever；wound infection；post-operation bleeding；ileus；stenosis；leakage