UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057091 |
|---|---|
| Receipt number | R000065235 |
| Scientific Title | Randomized controlled trial of energy devices in single-incision laparoscopic totally extraperitoneal inguinal hernia repair (SILS-TEP) |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/12/18 11:43:29 |
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Basic information
Public title
Randomized controlled trial of energy devices in single-incision laparoscopic totally extraperitoneal inguinal hernia repair (SILS-TEP)
Acronym
Comparative study of energy devices in SILS-TEP
Scientific Title
Randomized controlled trial of energy devices in single-incision laparoscopic totally extraperitoneal inguinal hernia repair (SILS-TEP)
Scientific Title:Acronym
Comparative study of energy devices in SILS-TEP
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the surgical outcomes of ultrasonic dissection and electrical dissection in SILS-TEP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of SILS-TEP
Key secondary outcomes
surgical complication rate, operation time, blood loss, recurrence rate, cost of surgical instruments, and postoperative quality of life (QOL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Performing SILS-TEP by ultrasonic dissection
Interventions/Control_2
Performing SILS-TEP by electrical dissection
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
Patients aged 20 years or older with unilateral inguinal hernia who are scheduled for SILS-TEP.
Key exclusion criteria
1) Patients with psychiatric illness or symptoms that make it difficult to participate in the study.
2) Patients for whom laparoscopic surgery is inappropriate.
3) Patients with bilateral inguinal hernias.
4) Patients with giant inguinal hernias.
5) Patients with severe conditions that the principal investigator or co-investigator determines are inappropriate for participation in this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Omori |
Organization
Osaka Keisatsu Hospital
Division name
Department of Gastroenterological Surgery
Zip code
543-8922
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
omori.takeshi05@oim.or.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Nakahara |
Organization
Osaka Keisatsu Hospital
Division name
Department of Gastroenterological Surgery
Zip code
543-8922
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
TEL
06-6771-6051
Homepage URL
nakahara.yujiro75@oim.or.jp
Sponsor or person
Institute
Osaka Keisatsu Hospital, Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Osaka Keisatu Hospital, Ethics committee
Address
2-6-40, Karasugatuji, Tennnouji-ku, Osaka 543-8922, Japan
Tel
06-6771-6051
shomu@oph.gr.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 20 | 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
62
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
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065235
