UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2019 Year 05 Month 31 Day
Date of IRB	2021 Year 05 Month 01 Day
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	2021 Year 10 Month 15 Day

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