Clinical trial · Interventional
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
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
NCT01742806CI-TRIAL-00008597unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bio-absorbable felt(NEOVEIL®) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control
- description
- not to use bio-absorbable felt(NEOVEIL®)
- type
- EXPERIMENTAL
- label
- NEOVEIL®
- description
- To use bio-absorbable felt
- interventionNames
- Device: bio-absorbable felt(NEOVEIL®)
Primary outcomes (1)
- measure
- Time to drain removal
- timeFrame
- two weeks
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDNakamura 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. PMID 2161571
- BACKGROUNDHayashibe 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. PMID 16788945
- BACKGROUNDUeda 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. PMID 19656529