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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name