The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,400
- Primary Endpoint
- complication
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional group
PG-SGA ≥2，<9
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
Intervention: perioperational nutrition surpport (Procedure)
Outcomes
Primary Outcomes
complication
Time Frame: 30 days after operation
fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
Secondary Outcomes
No secondary outcomes reported
Investigators
Quan Wang
Director
The First Hospital of Jilin University