NCT01742806

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

November 20, 2012

Last Update Submit

December 3, 2012

Conditions

Gastric Cancer

Keywords

Gastric cancerMinimally invasive surgeryDistal gastrectomyBio-absorbable Felt

Outcome Measures

Primary Outcomes (1)

  • 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.

    two weeks

Secondary Outcomes (1)

  • total amount of exudate drainage

    two weeks

Other Outcomes (1)

  • Time to discharge after surgery and postoperative complication

    up to 30days after randomization

Study Arms (2)

control

NO INTERVENTION

not to use bio-absorbable felt(NEOVEIL®)

NEOVEIL®

EXPERIMENTAL

To use bio-absorbable felt

Device: bio-absorbable felt(NEOVEIL®)

Interventions

bio-absorbable felt(NEOVEIL®)DEVICE

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)

Also known as: bio-absorbable polyglicolic acid felt,NEOVEIL®
NEOVEIL®

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Seoul National University College of Medicine, Bundang Hospital

Seongnam-si, Gyenggi-do, South Korea

RECRUITING

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

RECRUITING

Soonchunhyang University College of Medicine, Bucheon Hospital

Bucheon-si, South Korea

RECRUITING

Dong-A University College of Medicine

Busan, South Korea

RECRUITING

Seoul National University College of Medicine, Seoul National University Hospital

Seoul, South Korea

NOT YET RECRUITING

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 2161571BACKGROUND

  • 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.

    PMID: 16788945BACKGROUND

  • 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.

    PMID: 19656529BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • WOO JIN HYUNG, M.D. Ph.D.

    Yonsei University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WOO JIN HYUNG, M.D. Ph.D.

CONTACT

82-2-2228-2129wjhyung@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2012

First Posted

December 5, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

KR(7)