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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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bio-absorbable felt(NEOVEIL®)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University College of Medicine, Bundang HospitalRecruiting
  • Ajou University Medical CenterRecruiting
  • Soonchunhyang University College of Medicine, Bucheon HospitalRecruiting
  • Dong-A University College of MedicineRecruiting
  • Seoul National University College of Medicine, Seoul National University Hospital
  • The Catholic University of Korea, Yeouido St. Mary's HospitalRecruiting
  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

NEOVEIL®

Arm Description

not to use bio-absorbable felt(NEOVEIL®)

To use bio-absorbable felt

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

total amount of exudate drainage
Total amount of exudate after surgery is recorded.

Full Information

First Posted
November 20, 2012
Last Updated
December 3, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01742806
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
not to use bio-absorbable felt(NEOVEIL®)
Arm Title
NEOVEIL®
Arm Type
Experimental
Arm Description
To use bio-absorbable felt
Intervention Type
Device
Intervention Name(s)
bio-absorbable felt(NEOVEIL®)
Other Intervention Name(s)
bio-absorbable polyglicolic acid felt,NEOVEIL®
Intervention Description
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)
Primary Outcome Measure Information:
Title
Time to drain removal
Description
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 Outcome Measure Information:
Title
total amount of exudate drainage
Description
Total amount of exudate after surgery is recorded.
Time Frame
two weeks
Other Pre-specified Outcome Measures:
Title
Time to discharge after surgery and postoperative complication
Description
Time to discharge after surgery and postoperative complication are recorded
Time Frame
up to 30days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WOO JIN HYUNG, M.D. Ph.D.
Phone
82-2-2228-2129
Email
wjhyung@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WOO JIN HYUNG, M.D. Ph.D.
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University College of Medicine, Bundang Hospital
City
Seongnam-si
State/Province
Gyenggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D., Ph.D.
Facility Name
Ajou University Medical Center
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sang-Uk Han, M.D., Ph.D.
Facility Name
Soonchunhyang University College of Medicine, Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyu Seok Cho, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Gyu Seok Cho, M.D., Ph.D.
Facility Name
Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Chan Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Min-chan Kim, M.D., Ph.D.
Facility Name
Seoul National University College of Medicine, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, M.D.,Ph.D.
Facility Name
The Catholic University of Korea, Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WOOK KIM, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
WOOK KIM, M.D., Ph.D.
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WOO JIN HYUNG, M.D., Ph.D.
Email
wjhyung@yuhs.ac
First Name & Middle Initial & Last Name & Degree
WOO JIN HYUNG, M.D., Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
2161571
Citation
Nakamura T, Shimizu Y, Watanabe S, Hitomi S, Kitano M, Tamada J, Matsunobe S. New bioabsorbable pledgets and non-woven fabrics made from polyglycolide (PGA) for pulmonary surgery: clinical experience. Thorac Cardiovasc Surg. 1990 Apr;38(2):81-5. doi: 10.1055/s-2007-1013999.
Results Reference
background
PubMed Identifier
16788945
Citation
Hayashibe A, Sakamoto K, Shinbo M, Makimoto S, Nakamoto T. New method for prevention of bile leakage after hepatic resection. J Surg Oncol. 2006 Jul 1;94(1):57-60. doi: 10.1002/jso.20548.
Results Reference
background
PubMed Identifier
19656529
Citation
Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Sutureless pneumostasis using bioabsorbable mesh and glue during major lung resection for cancer: who are the best candidates? J Thorac Cardiovasc Surg. 2010 Mar;139(3):600-5. doi: 10.1016/j.jtcvs.2009.06.021. Epub 2009 Aug 4.
Results Reference
background

Learn more about this trial

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

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