UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012823 |
|---|---|
| Receipt number | R000014873 |
| Scientific Title | Randomized clinical trial of modified Kugel repair versus Lichtenstein repair in adult male patients with unilateral primary inguinal hernia |
| Date of disclosure of the study information | 2014/01/11 |
| Last modified on | 2019/08/01 10:49:08 |
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Basic information
Public title
Randomized clinical trial of modified Kugel repair versus Lichtenstein repair in adult male patients with unilateral primary inguinal hernia
Acronym
Randomized clinical trial of modified Kugel herniorrhaphy versus Lichtenstein repair
Scientific Title
Randomized clinical trial of modified Kugel repair versus Lichtenstein repair in adult male patients with unilateral primary inguinal hernia
Scientific Title:Acronym
Randomized clinical trial of modified Kugel herniorrhaphy versus Lichtenstein repair
Region
| Japan |
Condition
Condition
unilateral primary inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate operative outcomes of modified Kugel herniorrhaphy comparing with Lichtenstein repair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
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
2 years
modified Kugel herniorrhaphy
Interventions/Control_2
2 years
Lichtenstein herniorrhaphy
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
epualto or more 20 years old
male person
unilateral primary inguinal hernia
<ASA III
obtained a written informed consent
Key exclusion criteria
complicated hernia
female
simultaneous bilateral operation
equal to or more ASA IV
patients with pain due to other diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KATSUHITO |
| Middle name | |
| Last name | SUWA |
Organization
Daisan Hospital, The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
2018601
Address
4-11-1 Izumihoncho, Komae-city, Tokyo 201-8601, Japan
TEL
03-3480-1151
katsuhito-s@jikei.ac.jp
Public contact
Name of contact person
| 1st name | KATSUHITO |
| Middle name | |
| Last name | SUWA |
Organization
Daisan Hospital, The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
2018601
Address
4-11-1 Izumihoncho, Komae-city, Tokyo 201-8601, Japan
TEL
03-3480-1151
Homepage URL
katsuhito-s@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学付属第三病院
東京慈恵会医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014873
Publication of results
Unpublished
Result
URL related to results and publications
not yet
Number of participants that the trial has enrolled
200
Results
The incidence of chronic postoperative inguinal pain was similar for Lichtenstein and modified Kugel hernia repair (MKH). However, satisfaction score was higher in MKH due to less pain in the early postoperative period.
Results date posted
| 2019 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adult male person with primary unilateral inguinal hernia
Participant flow
participants were randomized with computer-generated method after obtaining written informed concent at out patient clinic
Adverse events
none
Outcome measures
primary endpoint: pain
secondary endpoint: recurrence, other complications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014873
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/08/01 | 第三＿外科＿成人男性初＿研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
