Gastric Cancer
Conditions
Keywords
Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt
Brief summary
This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.
Detailed description
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer. This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
Interventions
DEVICEbio-absorbable felt(NEOVEIL®)
To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologic confirmed gastric adenocarcinoma * Patients who underwent laparoscopic distal gastrectomy. * preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography. * patients who underwent more than D1+b lymphadenectomy
Exclusion criteria
* Vulnerable participants (pregnant women, under 20 year old, and so on) * liver or renal disease (Ex. liver cirrhosis, end stage renal disease) * Transfusion is needed preoperatively or postoperatively due to bleeding * Preoperative or intraoperative evaluation confirm ascites. * Patients who use anticoagulant preoperatively or postoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to drain removal | two weeks | Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total amount of exudate drainage | two weeks | Total amount of exudate after surgery is recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge after surgery and postoperative complication | up to 30days after randomization | Time to discharge after surgery and postoperative complication are recorded |
Countries
South Korea
Contacts
Primary ContactWOO JIN HYUNG, M.D. Ph.D.
Outcome results
None listed