Early Jejunostomy Nutrition Minimizes Time to Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01766765|
Recruitment Status : Unknown
Verified January 2013 by Qi Mao, Jinling Hospital, China.
Recruitment status was: Not yet recruiting
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
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).
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Laparoscopic Surgery Chemotherapy||Procedure: Jejunostomy Other: Early oral nutrition||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
|Experimental: Early jejunostomy 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
|Active Comparator: Early oral nutrition||
Other: Early oral nutrition
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766765
|Contact: Qi Mao, MD/PhDemail@example.com|
|Contact: Yousheng Li, MD/PhDfirstname.lastname@example.org|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator: Qi Mao, MD/PhD|
|Principal Investigator:||Qi Mao, MD/PhD||Jinling Hospital, China|