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

Yonsei University

Status: Unknown

Conditions: Gastric Cancer

Treatments: Device: bio-absorbable felt(NEOVEIL®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01742806

1-2012-0017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

control

No Intervention group

Description:

not to use bio-absorbable felt(NEOVEIL®)

NEOVEIL®

Experimental group

Description:

To use bio-absorbable felt

Treatment:

Device: bio-absorbable felt(NEOVEIL®)