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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Yonsei University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: November 20, 2012
Last updated: December 3, 2012
Last verified: December 2012
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.

Condition Intervention
Gastric Cancer
Device: bio-absorbable felt(NEOVEIL®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Time to drain removal [ Time Frame: 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:
  • total amount of exudate drainage [ Time Frame: two weeks ]
    Total amount of exudate after surgery is recorded.

Other Outcome Measures:
  • Time to discharge after surgery and postoperative complication [ Time Frame: up to 30days after randomization ]
    Time to discharge after surgery and postoperative complication are recorded

Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
not to use bio-absorbable felt(NEOVEIL®)
Experimental: NEOVEIL®
To use bio-absorbable felt
Device: bio-absorbable felt(NEOVEIL®)
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)
Other Name: bio-absorbable polyglicolic acid felt,NEOVEIL®

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01742806

Contact: WOO JIN HYUNG, M.D. Ph.D. 82-2-2228-2129

Korea, Republic of
Seoul National University College of Medicine, Bundang Hospital Recruiting
Seongnam-si, Gyenggi-do, Korea, Republic of
Contact: Hyung-Ho Kim, M.D., Ph.D.         
Principal Investigator: Hyung-Ho Kim, M.D., Ph.D.         
Ajou University Medical Center Recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Contact: Sang-Uk Han, M.D., Ph.D.         
Principal Investigator: Sang-Uk Han, M.D., Ph.D.         
Soonchunhyang University College of Medicine, Bucheon Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Gyu Seok Cho, M.D., Ph.D.         
Principal Investigator: Gyu Seok Cho, M.D., Ph.D.         
Dong-A University College of Medicine Recruiting
Busan, Korea, Republic of
Contact: Min-Chan Kim, M.D., Ph.D.         
Principal Investigator: Min-chan Kim, M.D., Ph.D.         
Seoul National University College of Medicine, Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Joon Lee, M.D., Ph.D.         
Principal Investigator: Hyuk-Joon Lee, M.D.,Ph.D.         
The Catholic University of Korea, Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: WOOK KIM, M.D. Ph.D.         
Principal Investigator: WOOK KIM, M.D., Ph.D.         
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: WOO JIN HYUNG, M.D., Ph.D.   
Principal Investigator: WOO JIN HYUNG, M.D., Ph.D.         
Sponsors and Collaborators
Yonsei University
Principal Investigator: WOO JIN HYUNG, M.D. Ph.D. Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01742806     History of Changes
Other Study ID Numbers: 1-2012-0017
Study First Received: November 20, 2012
Last Updated: December 3, 2012

Keywords provided by Yonsei University:
Gastric cancer
Minimally invasive surgery
Distal gastrectomy
Bio-absorbable Felt

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fibrin Tissue Adhesive
Coagulants processed this record on May 25, 2017