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
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: bio-absorbable felt(NEOVEIL®)
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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
Seoul National University College of Medicine, Bundang Hospital
Seongnam-si, Gyenggi-do, Korea, Republic of
Status: Recruiting
Contact: Hyung-Ho Kim, M.D., Ph.D.
Ajou University Medical Center
Suwon, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Sang-Uk Han, M.D., Ph.D.
Soonchunhyang University College of Medicine, Bucheon Hospital
Bucheon, Korea, Republic of
Status: Recruiting
Contact: Gyu Seok Cho, M.D., Ph.D.
Dong-A University College of Medicine
Busan, Korea, Republic of
Status: Recruiting
Contact: Min-Chan Kim, M.D., Ph.D.
Seoul National University College of Medicine, Seoul National University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Hyuk-Joon Lee, M.D., Ph.D.
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: WOOK KIM, M.D. Ph.D.
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: WOO JIN HYUNG, M.D., Ph.D. - wjhyung@yuhs.ac
Start Date
October 2012
Completion Date
June 2013
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page