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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043733
Receipt No. R000049926
Scientific Title The study about usefulness of a telesimulation curriculum for laparoscopic inguinal hernia repair
Date of disclosure of the study information 2021/03/25
Last modified on 2021/03/25

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Basic information
Public title The study about usefulness of a telesimulation curriculum for laparoscopic inguinal hernia repair
Acronym TAPP telesimulation curriculum
Scientific Title The study about usefulness of a telesimulation curriculum for laparoscopic inguinal hernia repair
Scientific Title:Acronym TAPP telesimulation curriculum
Region
Japan

Condition
Condition Inguinal Hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized controlled trial is to assess the effectiveness of telesimulation curriculum for laparoscopic inguinal hernia repair.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assess whether trainees' videotapeted performance before and after the trainings. They're assessed using GOALS-GH and TAPP checklist, developed for assessing TAPP performance.
Key secondary outcomes We assess whether trainees learn more about inguinal hernia due to online lecture and TAPP simulation training using examination before and after trainings.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Control group: self-training of TAPP simulation
Interventions/Control_2 Intervention group: tele-simulation training of TAPP
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Postgraduate year 2-5 surgeons or surgical residents who meet following criteria.
Residents operated no or one TAPP before their training.
Residents can suture with intracoporeal knot in simulation in 112 seconds refer to Fundamentals of Laparoscopic Surgery(FLS).
Key exclusion criteria Residents who get more than 15 with TAPP checklist in the skill test at the start of the study are excluded from the study because they already have better skill than the beginner level.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Hirano
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterological Surgery II
Zip code 060-8638
Address KIta 15 nishi 7, Kita Ward, Sapporo
TEL 0117067714
Email satto@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Kotoe
Middle name
Last name Kiriyama
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterological Surgery II
Zip code 060-8638
Address KIta 15 nishi 7, Kita Ward, Sapporo
TEL 0117067714
Homepage URL
Email kotoe.kiriyama@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Self Funded
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 Hokkaido University Graduate School of Medicine
Address KIta 15 nishi 7, Kita ward, Sapporo
Tel 011-706-5003
Email shomu@med.hokudai.ac.jp

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 製鉄室蘭病院(北海道)
手稲渓仁会病院(北海道)
旭川市立病院 (北海道)
自治医科大学附属病院(埼玉県)
沖縄県立中部病院(沖縄県)
市立釧路総合病院(北海道)
斗南病院(北海道)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 25 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 Enrolling by invitation
Date of protocol fixation
2021 Year 03 Month 17 Day
Date of IRB
2021 Year 03 Month 17 Day
Anticipated trial start date
2021 Year 03 Month 25 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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