UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039393 |
|---|---|
| Receipt number | R000044916 |
| Scientific Title | TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair |
| Date of disclosure of the study information | 2020/02/05 |
| Last modified on | 2020/02/05 13:10:02 |
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Basic information
Public title
TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Acronym
TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Scientific Title
TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Scientific Title:Acronym
TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Region
| Japan |
Condition
Condition
recurrent inguinal hernia
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Indication that recurrent inguinal hernia operations can be performed safely and reliably by using TAPP, iSTEP, or combined method after intraperitoneal observation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Assessment of recurrence and camplication rate.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 39 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patinents who underwent laparo-endoscopic surgery for recurrent inguinal hernia
Key exclusion criteria
Patients with a history of lower abdominal, pelvic, or prostate surgery.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Urushihara |
Organization
Hiroshima Prefectural Hospital
Division name
Department of Gastroenterological Surgery
Zip code
734-8530
Address
1-5-54 Ujina-kanda, Minami-ku, Hiroshima
TEL
+81-82-254-1818
urushihara1123@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Namba |
Organization
Chugoku Rosai Hospital
Division name
Department of Surgery
Zip code
737-0193
Address
1-5-1 Hiro-Tagaya, Kure
TEL
+81-823-72-7171
Homepage URL
yn_futt0711@yahoo.co.jp
Sponsor or person
Institute
Hiroshima Prefectural Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Prefectural Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Prefectural Hospital
Address
Department of Gastroenterological Surgery
Tel
+81-82-254-1818
urushihara1123@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 05 | 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
23
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Confirmation of recurrence and complications based on physical and imaging findings,
Management information
Registered date
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044916
