UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031112
Receipt No. 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 (Ver. 7)

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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
Email 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
Email nahoko323bear@yahoo.co.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035474