UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036458
Receipt number 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 2021/10/15 15:28:24

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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 or person

Institute

Kurashiki Central Hospital

Institute

Department

Personal name



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

Value
https://center6.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