An interventional study of enhanced recovery after surgery in Gastric Cancer, sponsored by Jinling Hospital, China. Status unknown at 23 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
In China, gastric cancer results in the second highest morbidity and mortality rates among all malignancies. It is very important for treatment of gastric cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. Now, "Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology" and "Japanese gastric cancer treatment guidelines 2014 (ver. 4)" recommended surgical resection for gastric cancer. As a result, increasing the quality of surgery and improving the perioperative measures have a great influence on patients received a gastrectomy. Before, patients discharged on 7-10 days after gastrectomy and recovered 4-8 weeks after surgery. So, it is significant for patients to recover from surgical trauma in order to receive other anti-cancer therapies after gastrectomy. Investigators spent over ten years studying enhanced recovery after surgery programs for gastric cancer and have got some successful experience. Investigators found enhanced recovery after surgery can accelerate patients' recovery without increasing complications.
This study is the first multi-center study of enhanced recovery after surgery for gastric cancer all over the world. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 1,000 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:
enhanced recovery after surgery includes: 1. Multimodal analgesia 2. Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet 3. Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early 4. Early activity 5. Perioperative controlled infusion A: Load carbohydrate preoperatively B: No preoperative bowel preparation C: Fast six hours before surgery, no drink two hours before surgery D: Intraoperative liquid management: 3-6ml/kg/h, determined by anesthetists E: Stop intravenous infusion upon 2000-2500ml water and semiliquid diet being taken
Procedure: enhanced recovery after surgery
Undergo an enhanced recovery after surgery program
occurrence rate of severe complications
including death, anastomotic fistula, intra-abdominal hemorrhage, hemorrhage of digestive tract and complications need a reoperation
Time frame: 1 month
Occurrence rate of ordinary complications
Except severe complications, Clavien-Dindo classification ≥Ⅱ complications need not reoperation
Time frame: 1 month
Readmission rate within 30 days after discharge
Readmission rate within 30 days after discharge
Time frame: 1 month
Ideal postoperative length of hospital stay
reach discharge criteria
Time frame: 1 month
Actual postoperative length of hospital stay
Actual postoperative length of hospital stay
Time frame: 1 month
Operative time
Data of operation
Time frame: 1 day
Blood loss
Data of operation
Time frame: 1 day
Intraoperative infusion
Data of operation
Time frame: 1 day
TNM classification
Data of tumor
Time frame: 1 week
Number of dissected lymph node
Data of tumor
Time frame: 1 week
Time to first flatus
Bowel function recovery
Time frame: 2 week
Time to first defecation
Bowel function recovery
Time frame: 2 week
Time to first semi-liquid diet
Bowel function recovery
Time frame: 2 week
Time to first off-bed activity
Postoperative activity
Time frame: 1 week
Time of off-bed activity per day
Postoperative activity
Time frame: 1 week
Distance of off-bed activity per day
Postoperative activity
Time frame: 1 week
Postoperative pain
VAS classification
Time frame: 1 week
Hospital cost
Hospital cost
Time frame: 1 month
Management of catheters
including nasogastric tube, catheter, intraperitoneal drain, infusion tube
Time frame: 1 month
Preoperative length of hospital stay
Preoperative length of hospital stay
Time frame: 1 month
CD3+
Immune indicators
Time frame: 1 week
CD4+
Immune indicators
Time frame: 1 week
CD4+/CD8+
Immune indicators
Time frame: 1 week
IL-6
Inflammatory indicators
Time frame: 1 week
CRP
Inflammatory indicators
Time frame: 1 week
Albumin
Nutritional indicators
Time frame: 1 week
Prealbumin
Nutritional indicators
Time frame: 1 week
Transferrin
Nutritional indicators
Time frame: 1 week
Hb
Nutritional indicators
Time frame: 1 week
WBC
Nutritional indicators
Time frame: 1 week
PLT
Nutritional indicators
Time frame: 1 week
HCT
Nutritional indicators
Time frame: 1 week
Blood glucose
Nutritional indicators
Time frame: 1 week
Procalcitonin
Infectious indicator
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Jinling Hospital, China