Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer: Multicenter Prospective Randomized Comparison Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: bio-absorbable felt(NEOVEIL®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>not to use bio-absorbable felt(NEOVEIL®) | |
| Experimental: NEOVEIL®<br>To use bio-absorbable felt | Device: bio-absorbable felt(NEOVEIL®)<br>* 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)<br>* Other names: bio-absorbable polyglicolic acid felt,NEOVEIL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to drain removal | Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding. | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total amount of exudate drainage | Total amount of exudate after surgery is recorded. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt