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

Jilin University

Status: Unknown

Conditions: Nutrition Disorders

Treatments: Procedure: perioperational nutrition surpport

Study type: Interventional

Funder types: Other

Identifiers

NCT03043183

ERAS AND Nutritional Status

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.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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,400 participants in 2 patient groups

Preoperational nutrition support group

Experimental group

Description:

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

Treatment:

Procedure: perioperational nutrition surpport

Conventional group

No Intervention group

Description:

PG-SGA ≥2，\<9