A Phase 4 interventional study of Jejunostomy and Early oral nutrition in Gastric Cancer, Laparoscopic Surgery and Chemotherapy, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-11.
Sponsored by Jinling Hospital, China · Phase 4, Interventional, and Supportive care
Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube for enteral nutrition is a common component of these procedures, as a result of superior postoperative organ function, decreased infection rates, and a greater likelihood to complete AC with enteral nutritional support.
Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in reductions in total complications compared with traditional postoperative feeding practices and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube routine placement and combination with FTS is still being debated. Besides, there remains some controversy over the optimal combination of nutrients and duration and timing and routes of feed administration.
The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN) following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and minimizes time to AC when compared with FTS with early oral nutrition (EON).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Jejunostomy
Other: Early oral nutrition
Routine placement of jejunostomy tube following laparoscopic gastrectomy for gastric cancer. Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube
Free oral nutrition as tolerance allows on POD 1.
The time to the first adjuvant chemotherapy
Time frame: 30 days after operation
Overall morbidity rate of jejunostomy nutrition
Time frame: 60 days after operation
Overall morbidity rate of early oral nutrition
Time frame: 60 days after operation
Postoperative mortality rate
Time frame: 60 days after operation
Time to tolerate EJN/EON
Time frame: 30 days after operation
Time to full oral nutrition
Time frame: 30 days after operation
Body composition
Time frame: 10 days after operation
Energy metabolism
Time frame: 10 days after operation
Postoperative hospital stay length
Time frame: 60 days after operation
Rehospitalization rate
Time frame: 30 days after discharge
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Jinling Hospital, China