UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003710
Receipt No. R000004491
Scientific Title Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method
Date of disclosure of the study information 2010/07/01
Last modified on 2014/09/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method
Acronym Efficacy of a lightweight mesh in inguinal hernia repair
Scientific Title Randomized clinical trial assessing impact of a heavyweight or lightweight mesh on chronic pain after inguinal hernia repair by mesh-plug method
Scientific Title:Acronym Efficacy of a lightweight mesh in inguinal hernia repair
Region
Japan

Condition
Condition Adult cases of inguinal hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether the chronic pain after inguinal hernia repair by mesh-plug method can be suppressed by the use of lightweight mesh, compared with conventional heavyweight mesh.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Occurrence and/or magnitude of chronic pain and discomfort after inguinal hernia repair.
Key secondary outcomes Recurrence of hernia
Occurrence of postoperative infectious complications.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use of the lightweight mesh
Interventions/Control_2 Use of the heavyweight 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 and Female
Key inclusion criteria Cases scheduled to undergo inguinal hernia repair in Nagoya Daini Red Cross Hospital
Key exclusion criteria In case other surgical management than mesh-plug method is employed.
Strangulation of hernia.
Cases of recurrent hernia.
In case lumber anesthesia is needed.
Those who underwent hernia repair of the other side within a year.
Those who needed a constant use of painkillers due to other chronic diseases.
In case significant changes are needed in the planning of surgery (e.g. femoral hernia).
Those who cannot understand the concept of the study (e.g. dementia or mental disorders).
Patients who cannot respond our scheduled questionnaire after the surgery.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichiro Komatsu
Organization Nagoya Daini Red Cross Hospital
Division name Surgery
Zip code
Address 2-9, Myoukencho, Showaku, Nagoya City, Aichi Pref.
TEL 052-832-1121
Email skomat@nagoya2.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichiro Komatsu
Organization Nagoya Daini Red Cross Hospital
Division name Surgery
Zip code
Address 2-9, Myoukencho, Showaku, Nagoya City, Aichi Pref.
TEL 052-832-1121
Homepage URL
Email skomat@nagoya2.jrc.or.jp

Sponsor
Institute Nagoya Daini Red Cross Hospital
Institute
Department

Funding Source
Organization Ethicon, Inc., Somerville, New Jersey
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋第二赤十字病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s10029-013-1105-8
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 Completed
Date of protocol fixation
2009 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 04 Day
Last modified on
2014 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004491

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.