UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009916
Receipt No. R000011619
Scientific Title Randomized, Controlled, Blinded Trial of Mesh Fixation in Patients Undergoing UPP Technique for Primary Inguinal Hernia Repair
Date of disclosure of the study information 2013/02/01
Last modified on 2015/08/18

* 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, Controlled, Blinded Trial of Mesh Fixation in Patients Undergoing UPP Technique for Primary Inguinal Hernia Repair
Acronym Randomized, Controlled, Blinded Trial of Mesh Fixation in Patients Undergoing UPP Technique for Primary Inguinal Hernia Repair
Scientific Title Randomized, Controlled, Blinded Trial of Mesh Fixation in Patients Undergoing UPP Technique for Primary Inguinal Hernia Repair
Scientific Title:Acronym Randomized, Controlled, Blinded Trial of Mesh Fixation in Patients Undergoing UPP Technique for Primary Inguinal Hernia Repair
Region
Japan

Condition
Condition Patients over 20 years of age with a unilateral primary inguinal hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to assess whether the suture fixation of an on-lay mesh for UPP in primary inguinal hernia repair could reduce pain or other symptoms associated with the insertion of the prosthesis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain and other symptoms at the site of hernia repair
Key secondary outcomes Hernia recurrence
Postoperative 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 NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Suture fixation of an on-lay mesh
Interventions/Control_2 No fixation of an on-lay 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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with a unilateral primary inguinal hernia.
Patients planned to undergo elective surgery for inguinal hernia repair using the UPP technique with local anesthesia.
Key exclusion criteria The need for other treatment.
A hernia with strangulation.
A femoral hernia.
An emergency operation.
A recurrent hernia.
A bilateral hernia at first visit.
The need for other anesthesia.
A history of an operation for an opposite inguinal hernia within 1 year.
The use of painkillers for another disease.
A lack of understanding of the study's concept.
The impossibility of periodic assessments after hospital discharge.
Target sample size 270

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Shingu
Organization Nagoya Daini Red Cross Hospital
Division name Department of Surgery
Zip code
Address 2-9 Myoken-cho, showa-ku, Nagoya City, Aichi Pref.
TEL 052-832-1121
Email shingu@nagoya2.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Shingu
Organization Nagoya Daini Red Cross Hospital
Division name Department of Surgery
Zip code
Address 2-9 Myoken-cho, showa-ku, Nagoya City, Aichi Pref.
TEL 052-832-1121
Homepage URL
Email shingu@nagoya2.jrc.or.jp

Sponsor
Institute Nagoya Daini Red Cross Hospital
Institute
Department

Funding Source
Organization Nagoya Daini Red Cross Hospital
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 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
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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 31 Day
Last modified on
2015 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.