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

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Device: bio-absorbable felt(NEOVEIL®)

• Registration Number: NCT01742806
• Lead Sponsor: Yonsei University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-20
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-05
• Last Update Posted: 2012-12-05
• Primary Completion: 2013-04
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEOVEIL®	bio-absorbable felt(NEOVEIL®)	To use bio-absorbable felt

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
total amount of exudate drainage	two weeks	Total amount of exudate after surgery is recorded.

Trial Locations

Locations (7)

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Dong-A University College of Medicine; 🇰🇷 Busan, Korea, Republic of

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University College of Medicine, Bundang Hospital; 🇰🇷 Seongnam-si, Gyenggi-do, Korea, Republic of

Soonchunhyang University College of Medicine, Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Ajou University Medical Center; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of

Seoul National University College of Medicine, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of