UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054210 |
|---|---|
| Receipt number | R000061900 |
| Scientific Title | Is fixation of mesh necessary during laparoscopic transabdominal preperitoneal repair? Randomized controlled trial (TAPP-MEISTER Trial) |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/04/21 09:09:49 |
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Basic information
Public title
Is fixation of mesh necessary during laparoscopic transabdominal preperitoneal repair? Randomized controlled trial (TAPP-MEISTER Trial)
Acronym
Is fixation of mesh necessary during TAPP? Randomized controlled trial (TAPP-MEISTER Trial)
Scientific Title
Is fixation of mesh necessary during laparoscopic transabdominal preperitoneal repair? Randomized controlled trial (TAPP-MEISTER Trial)
Scientific Title:Acronym
Is fixation of mesh necessary during TAPP? Randomized controlled trial (TAPP-MEISTER Trial)
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present open label randomized cotrolled trial is to test the non-inferiority of no mesh fixation compared to mesh fixation using tacker in terms of recurrence rate at 1 year after transabdominal preperitoneal repair (TAPP) in adult patients with inguinal hernia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate at 1 year after TAPP
Key secondary outcomes
Duration of Surgery, Intra- and postoperative complication, The strongest pain intensity, pain intensity at rest, and pain intensity during daily life at 1 year after TAPP, Discomfortable sensation, Paresthesia, Ejaculation pain, Erection pain, Duration between surgery and getting back to the normal living, risk factors associated with pain at 1 year after TAPP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mesh fixation using tackerixation using tacker
Interventions/Control_2
No mesh fixation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with inguinal hernia planned to undergo elective TAPP
2) Patients with 18 years old or more and can decide to participate in the present trial by theirselves.
3) Patients who can visit the outpatient clinic at 1 year after TAPP
Key exclusion criteria
1) Patients having L3 or M3 hernia according to the EHS guidelines
2) Patients planned to undergo surgery for chronic pain or recurrece
3) Patients with postoperative status of radical prostatectomy
4) Patients planned to undergo surgery for bilateral inguinal hernia
5) Patients planned to undergo surgery for femoral hernia
6) Patients planned to undergo surgery for concomitant surgery for another disease
7) Patients who are deemed to be an inappropriate case to participate in the present trial by their doctor
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Surgery
Zip code
650-0047
Address
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-302-4321
narinari@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Narita |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Surgery
Zip code
6500047
Address
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-302-4321
Homepage URL
narinari@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Masato Narita
Funding Source
Organization
self-procured
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city hospital organization certified review board
Address
Kobe City Medical Center General Hospital
Tel
078-302-4321
narinari@kuhp.kyoto-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
神戸市立医療センター中央市民病院 外科
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2024 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2024 | Year | 04 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061900
