Chemotherapy, Gastric Cancer, Laparoscopic Surgery
Conditions
Brief summary
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).
Interventions
OTHEREarly oral nutrition
Free oral nutrition as tolerance allows on POD 1.
PROCEDUREJejunostomy
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
Sponsors
National Natural Science Foundation of China
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Primary gastric cancer * R0 resection
Exclusion criteria
* Metastatic tumor * Locally unresectable tumor * Previous gastric/enteral resection * Age under 18 years or over 70 years * Preoperative complete parenteral or enteral nutrition * Neo-adjuvant chemotherapy * Severe malnutrition * Lack of the patient's consent for the trial participation, jejunostomy tube insertion or epidural analgesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to the first adjuvant chemotherapy | 30 days after operation |
Secondary
| Measure | Time frame |
|---|---|
| Rehospitalization rate | 30 days after discharge |
| Energy metabolism | 10 days after operation |
| Overall morbidity rate of jejunostomy nutrition | 60 days after operation |
| Overall morbidity rate of early oral nutrition | 60 days after operation |
| Postoperative hospital stay length | 60 days after operation |
| Time to tolerate EJN/EON | 30 days after operation |
| Time to full oral nutrition | 30 days after operation |
| Body composition | 10 days after operation |
| Postoperative mortality rate | 60 days after operation |
Countries
China
Contacts
Primary ContactQi Mao, MD/PhD
Backup ContactYousheng Li, MD/PhD
Outcome results
None listed