Clinical trial NCT01742806: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric cancer
Minimally invasive surgery
Distal gastrectomy
Bio-absorbable Felt
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to drain removal
timeFrame: two weeks
Secondary outcomes:
measure: total amount of exudate drainage
timeFrame: two weeks
Other outcomes:
measure: Time to discharge after surgery and postoperative complication
timeFrame: up to 30days after randomization
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University College of Medicine, Bundang Hospital
state: Gyenggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University College of Medicine, Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University
name: WOO JIN HYUNG, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.