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
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
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
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
