UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020097 |
|---|---|
| Receipt number | R000023152 |
| Scientific Title | An Observational Study of Recurrence of Inguinal Hernia After Repair Using Parietex Lap-Progrip |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2016/01/05 15:12:25 |
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Basic information
Public title
An Observational Study of Recurrence
of Inguinal Hernia After Repair
Using Parietex Lap-Progrip
Acronym
An Observational Study of Recurrence
of Inguinal Hernia After Repair
Using Parietex Lap-Progrip
Scientific Title
An Observational Study of Recurrence
of Inguinal Hernia After Repair
Using Parietex Lap-Progrip
Scientific Title:Acronym
An Observational Study of Recurrence
of Inguinal Hernia After Repair
Using Parietex Lap-Progrip
Region
| Japan |
Condition
Condition
inguinal herunia
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate recurrence rate of inguinal hernia and associated adverse events after laparoscopic inguinal hernia repair (TAPP) using the Parietex Lap-Progrip, under coverage of the general health insurance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hernia recurrence rate within 2 year following the procedure
Key secondary outcomes
1)Postoperative pain (Numeric Rating Scale)
2)Adverse events (bleeding, selome, hematoma, infection, edema, allergic reaction to the products structural materials, intestinal obstruction, and urinary retention due to anesthesia)
3)Patient satisfaction level
4)Operative time
5)Length of hospital stay
6)No of Parietex Lap-Progrip used, cost
7)Whether trimming is required or not
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1)20 years old or older
2)Written informed consent for study participation has been obtained from the patient.
3)Patients who can be followed for 24 months or more postoperatively.
Key exclusion criteria
1)Recurrent inguinal hernia
2)Emergency surgery
3)Patients with incarcerated hernia
4)Other patients judged by the investigator to be inappropriate to participate in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Fukunaga |
Organization
Juntendo University Urayasu Hospital
Division name
Surgical Department
Zip code
Address
2-1-1 Tomioka, Urayasu-shi, Chiba 279-0021
TEL
047-353-3111
masaki-f@juntendo-urayasu.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Ouchi |
Organization
Juntendo University Urayasu Hospital
Division name
Surgical Department
Zip code
Address
2-1-1 Tomioka, Urayasu-shi, Chiba 279-0021
TEL
047-353-3111
Homepage URL
ouchimasakazu@yahoo.co.jp
Sponsor or person
Institute
Juntendo University Urayasu HospitalSurgical Department
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
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
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
順天堂大学医学部附属浦安病院
Juntendo University Urayasu Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | 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
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type: Single group observational study
Inclusion criteria:
Patients scheduled to undergo laparoscopic inguinal hernia repair (TAPP) under coverage of the general health insurance and to be adapted specific inclusion criteria are included.
Participant enrollment period: From July 1, 2015 to December 31, 2016
Endpoints: All inguinal hernia recurrence rates within 2 year postoperatively, Postoperative pain, Postoperative adverse events, Patient satisfaction level, Operative time, Length of hospital stay, Number of Parietex Lap-Progrip products used, cost, Trimming required or not
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023152
