UMIN-CTR Clinical Trial

Basic information
Public title	TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Acronym	TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Scientific Title	TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Scientific Title:Acronym	TAPP, TEP, or Combined method by laparo-endoscopic single-site surgery for recurrent inguinal hernia repair
Region	Japan

Condition
Condition	recurrent inguinal hernia
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Indication that recurrent inguinal hernia operations can be performed safely and reliably by using TAPP, iSTEP, or combined method after intraperitoneal observation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Assessment of recurrence and camplication rate.
Key secondary outcomes

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	39 years-old <=
Age-upper limit	82 years-old >=
Gender	Male and Female
Key inclusion criteria	Patinents who underwent laparo-endoscopic surgery for recurrent inguinal hernia
Key exclusion criteria	Patients with a history of lower abdominal, pelvic, or prostate surgery.
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Urushihara
Organization	Hiroshima Prefectural Hospital
Division name	Department of Gastroenterological Surgery
Zip code	734-8530
Address	1-5-54 Ujina-kanda, Minami-ku, Hiroshima
TEL	+81-82-254-1818
Email	urushihara1123@gmail.com

Public contact
Name of contact person	1st name Yosuke Middle name Last name Namba
Organization	Chugoku Rosai Hospital
Division name	Department of Surgery
Zip code	737-0193
Address	1-5-1 Hiro-Tagaya, Kure
TEL	+81-823-72-7171
Homepage URL
Email	yn_futt0711@yahoo.co.jp

Sponsor
Institute	Hiroshima Prefectural Hospital
Institute
Department

Funding Source
Organization	Hiroshima Prefectural Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hiroshima Prefectural Hospital
Address	Department of Gastroenterological Surgery
Tel	+81-82-254-1818
Email	urushihara1123@gmail.com

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	2020 Year 02 Month 05 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	23
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	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 11 Month 02 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Confirmation of recurrence and complications based on physical and imaging findings,

Management information
Registered date	2020 Year 02 Month 05 Day
Last modified on	2020 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044916