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

Nutrition Disorders Clinical Trial

Official title:

The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03043183
• Other study ID #: ERAS AND Nutritional Status
• Status: Not yet recruiting
• Phase: N/A
• First received: February 2, 2017
• Last updated: February 3, 2017
• Start date: March 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2017
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: September 30, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nutrition Disorders
• Stomach Neoplasms

Intervention

Procedure:
• perioperational nutrition surpport
Oral enteral nutrition support(25 kcal/kg or 1.5 g protein/kg) for 3 days before operation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication	fever;wound infection;post-operation bleeding;ileus;stenosis;leakage	30 days after operation