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

NCT ID: NCT03043183

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-09-30

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.

Conditions

Nutrition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Preoperational nutrition support group

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

Group Type: EXPERIMENTAL

perioperational nutrition surpport

Intervention Type: PROCEDURE

Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation

Conventional group

PG-SGA ≥2，\<9

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

perioperational nutrition surpport

Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ERAS AND Nutritional Status

Identifier Type: -

Identifier Source: org_study_id