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

December 3, 2012 updated by: Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • bio-absorbable polyglicolic acid felt,NEOVEIL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total amount of exudate drainage
Time Frame: two weeks
Total amount of exudate after surgery is recorded.
two weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: WOO JIN HYUNG, M.D. Ph.D., Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2012-0017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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