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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012823
Receipt No. 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

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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
Email 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
Email katsuhito-s@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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