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Clinical Trials/NCT03043183
NCT03043183
Unknown
Not Applicable

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

The First Hospital of Jilin University0 sites1,400 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition Disorders
Sponsor
The First Hospital of Jilin University
Enrollment
1400
Primary Endpoint
complication
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
September 30, 2021
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Quan Wang

Director

The First Hospital of Jilin University

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.

Outcomes

Primary Outcomes

complication

Time Frame: 30 days after operation

fever;wound infection;post-operation bleeding;ileus;stenosis;leakage

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