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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036458
Receipt No. R000041549
Scientific Title Feasibility of a novel tacking method of securing mesh in transabdominal preperitoneal inguinal hernia repair
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/09

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Basic information
Public title Feasibility of a novel tacking method of securing mesh in transabdominal preperitoneal inguinal hernia repair
Acronym Feasibility of a novel tacking method in TAPP
Scientific Title Feasibility of a novel tacking method of securing mesh in transabdominal preperitoneal inguinal hernia repair
Scientific Title:Acronym Feasibility of a novel tacking method in TAPP
Region
Japan

Condition
Condition inguinal hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In TAPP hernia repair in Japan, the mesh is most commonly fixed by tacking, usually around the perimeter of the mesh outside the trapezoid of disaster.In many cases, this type of tacking is sufficient, but in cases of recurrence, the mesh may lift. If a new procedure that tacks the mesh more securely without pain can be found, hernia recurrences may become a thing of the past. For this reason, we created a new technique to reduce the risk of recurrence after TAPP repair. The purpose of this study was to evaluate the occurrence of postoperative neuralgias proximal to the trapezoid of disaster after TAPP procedures using this technique.
Basic objectives2 Others
Basic objectives -Others Recurrence, Psotoperative Pain
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of Chronic pain or paresthesia in postoperative month three.


Key secondary outcomes recurrence rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We performed a novel tacking method in which patients had at least three tacks placed on Coopers ligament and the transverse abdominal muscle and had an extra tack placed at the trapezoid of disasterusing a fixation device.
Interventions/Control_2
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
100 years-old >=
Gender Male and Female
Key inclusion criteria All TAPP cases in our insutitutes
Key exclusion criteria Preoperative pain
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Nagahisa
Organization Kurashiki Central Hospital
Division name Department of surgery
Zip code 7108602
Address Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, Japan.
TEL 0864228610
Email nagahisa440@yahoo.co.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Nagahisa
Organization Kurashiki Central Hospital
Division name Department of surgery
Zip code 7108602
Address Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 0864228610
Homepage URL
Email nagahisa440@yahoo.co.jp

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) none

IRB Contact (For public release)
Organization Kurashiki Centaral Hospital
Address Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel 0864228610
Email nagahisa440@yahoo.co.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 静岡市立静岡病院 

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041549

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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