UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029683 |
|---|---|
| Receipt number | R000033920 |
| Scientific Title | Evaluation of surgical conditions during laparoscopic totally extraperitoneal repair for inguinal hernia with deep vs non neuromuscular blockade. |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2022/04/28 09:22:17 |
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Basic information
Public title
Evaluation of surgical conditions during laparoscopic totally extraperitoneal repair for inguinal hernia with deep vs non neuromuscular blockade.
Acronym
The effect of neuromusucular blockade during TEP surgery.
Scientific Title
Evaluation of surgical conditions during laparoscopic totally extraperitoneal repair for inguinal hernia with deep vs non neuromuscular blockade.
Scientific Title:Acronym
The effect of neuromusucular blockade during TEP surgery.
Region
| Japan |
Condition
Condition
Patients scheduled for elective laparoscopic totally extraperitoneal repair for inguinal hernia under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of neuromuscular blockade for laparoscopic totally extraperitoneal repair for inguinal hernia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of surgical conditions assessed by the surgion between patients with and without neuromuscular blockade.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with neuromuscular blocking agents during surgery.
Interventions/Control_2
Patients without neuromuscular blocking agents during surgery.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective laparoscopic totally extraperitoneal repair for inguinal hernia under general anesthesia
Key exclusion criteria
Patients with cirrhosis, hepatitis, cholestasis, heart failure, renal dysfunction, obesity, gastroesophageal reflux, neuromuscular disorders
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Nishinihon Hospital
Division name
Department of Anesthesiology
Zip code
8618034
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL
096-380-1111
mfujimoto-kmm@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Nishinihon Hospital
Division name
Department of Anesthesiology
Zip code
8618034
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
TEL
096-380-1111
Homepage URL
mfujimoto-kmm@umin.ac.jp
Sponsor or person
Institute
Nishinihon Hospital
Institute
Department
Personal name
Funding Source
Organization
Nishinihon 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
The ethics committee of Nishinihon Hospital
Address
3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto, Japan
Tel
096-380-1111
jimubu@nishinihon.or.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
西日本病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
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 | 10 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2017 | Year | 10 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033920
