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 University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Gastric Cancer

Interventions

bio-absorbable felt(NEOVEIL®)DEVICE

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)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (7)

Seoul National University College of Medicine, Bundang Hospital

Seongnam-si, Gyenggi-do, South Korea

RECRUITING

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

RECRUITING

Soonchunhyang University College of Medicine, Bucheon Hospital

Outcomes

Primary Outcomes

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.

Time frame: two weeks

Secondary Outcomes

total amount of exudate drainage

Total amount of exudate after surgery is recorded.

Time frame: two weeks

Central Contacts

WOO JIN HYUNG, M.D. Ph.D.

CONTACT

82-2-2228-2129 wjhyung@yuhs.ac

Data from ClinicalTrials.gov

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