UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031112 |
|---|---|
| Receipt number | R000035474 |
| Scientific Title | A Prospective, Randomized, Controlled Trial of the use of Oxidized Cellulose for Video-Assisted Thoracic Surgery |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2019/12/10 14:34:39 |
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Basic information
Public title
A Prospective, Randomized, Controlled Trial of the use of Oxidized Cellulose for Video-Assisted Thoracic Surgery
Acronym
Oxidized Cellulose use for VATS
Scientific Title
A Prospective, Randomized, Controlled Trial of the use of Oxidized Cellulose for Video-Assisted Thoracic Surgery
Scientific Title:Acronym
Oxidized Cellulose use for VATS
Region
| Japan |
Condition
Condition
Lung disease requiring lung resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is examining the effectiveness of surgery by using oxidized cellulose for wound surface in Video-Assisted Thoracic Surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative visual field injury due to wound bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lobectomy was performed through a 3cm utility incision and three 2cm access ports, and lung wedge resection was performed through a 3cm utility incision and two 2cm access ports. For the intervention group, oxidized cellulose is used for surgical wound surface.The oxidized cellulose sheets(ORC sheets) were cut to 1.5*13cm for the utility incision and 1.5*8cm for the access port and were then rolled around the narrow portion of a wound edge protector.Remove both oxidized cellulose sheet and protector at the end of surgery.
Interventions/Control_2
A wound edge protector is used for the utility incision and each access port, and perform a normal thoracoscopic lung resection.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are planned to undergo pulmonary resection more than thoracoscopic partial resection under general anesthesia
2)Age at consent acquisition is over 20 years old
3)Patients who gave adequate explanation on participation of this study and obtained consent
Key exclusion criteria
1)The case which was high degree of adhesion
2)The case in which protector can not be worn because of physique
3)The case which needed conversion to thoracotomy
4)The cases judged inappropriate by the attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Maniwa |
Organization
Kobe University Hospital
Division name
Department of General Thoracic Surgery
Zip code
650-0017
Address
Research Building A, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo 650-0017, Japan
TEL
078-382-5750
kgts@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Nahoko |
| Middle name | |
| Last name | Shimizu |
Organization
Kobe University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
650-0017
Address
Research Building A, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo 650-0017, Japan
TEL
078-382-5750
Homepage URL
nahoko323bear@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
Research Building A, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo 650-0017, Japan
Tel
0783826669
chiken@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
The use of an ORC sheet around a wound edge protector decreased an interruption in the operation as a result of blood oozing from the surface of the access port wound and the number of wound edge hemostatic procedures upon wound closure. Although the application of ORC did not affect rates of wound complications, major intraoperative hemorrhage, conversion to thoracotomy, and postoperative mortality, it improved the operation time.
Results date posted
| 2019 | Year | 12 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035474
