UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050603 |
|---|---|
| Receipt number | R000057639 |
| Scientific Title | Tension-Free Aponeuroplasty Versus Prosthetic Mesh for Inguinal Hernia Repair in a Resource-Limited Setting: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2023/03/16 |
| Last modified on | 2023/03/16 01:40:42 |
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Basic information
Public title
Tension-Free Aponeuroplasty Versus Prosthetic Mesh for Inguinal Hernia Repair in a Resource-Limited Setting
Acronym
hernia repair
Scientific Title
Tension-Free Aponeuroplasty Versus Prosthetic Mesh for Inguinal Hernia Repair in a Resource-Limited Setting: A Randomized Clinical Trial
Scientific Title:Acronym
Tension-Free Aponeuroplasty Versus Prosthetic Mesh for Inguinal Hernia Repair
Region
| Asia(except Japan) |
Condition
Condition
unilateral primary inguinal hernia
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of the Tension-Free Aponeuroplasty and Prosthetic Mesh for inguinal hernia repair regarding to postoperative pain, surgical site infection, and recurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of chronic pain.
Key secondary outcomes
other operative outcomes (operation time, postoperative stay, return to daily activity, complications, sensory disorders, recurrence rate...)
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Herniorrhaphy with Tension-Free Aponeuroplasty
Interventions/Control_2
Herniorrhaphy with Artificial Mesh
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
| Not applicable |
Gender
Male
Key inclusion criteria
Age more 20 years old
Male person
Unilateral primary inguinal hernia
American Society of Anesthesiologists Classification less than three
Obtained a written informed consent
Key exclusion criteria
Patient with chronic cough
Patients with obstructive lung disease
Patients with a history of smoking or constipation
Recurrent hernia
Female patients
Simultaneous bilateral operation
American Society of Anesthesiologists Classification less than three equal or more three
Patients with scrotal or inguinal pain due to other diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Saif |
| Middle name | |
| Last name | Ghabisha |
Organization
Al-thora Hospital, Ibb university
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Al-Thora General Hospital, Alodine street, Ibb, Yemen
TEL
00967776089579
saifalighabisha@yahoo.com
Public contact
Name of contact person
| 1st name | Faisal |
| Middle name | |
| Last name | Ahmed |
Organization
Al-thora Hospital, Ibb university
Division name
Department of Surgery
Zip code
PO Box 70270
Address
Al-Thora General Hospital, Alodine Street, Ibb, Yemen
TEL
00967776089579
Homepage URL
fmaaa2006@yahoo.com
Sponsor or person
Institute
Ibb University
Institute
Department
Personal name
Funding Source
Organization
Ibb University
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
Research Ethics Committees of Ibb University, Faculty of Medicine and Health Science
Address
Research Ethics Committees of Ibb University, Faculty of Medicine and Health Science, Ibb University, Ibb City, Ibb, Yemen
Tel
009674416416
P.studies@ibbuniv.edu.ye
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
| 2023 | Year | 03 | Month | 16 | 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
200
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
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057639
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/03/16 | Research Plan.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/03/16 | Research case data specifications.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/03/16 | Research case data f.docx |
