UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057932 |
|---|---|
| Receipt number | R000066230 |
| Scientific Title | Effect of a wearable chair on surgeon strain and fatigue during laparoscopic inguinal hernia repair: an open-label randomized controlled pilot study. |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/21 19:42:30 |
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Basic information
Public title
Effect of a wearable chair on surgeon strain and fatigue during laparoscopic inguinal hernia repair: an open-label randomized controlled pilot study.
Acronym
Effect of a wearable chair on surgeon strain and fatigue during laparoscopic inguinal hernia repair: an open-label randomized controlled pilot study.
Scientific Title
Effect of a wearable chair on surgeon strain and fatigue during laparoscopic inguinal hernia repair: an open-label randomized controlled pilot study.
Scientific Title:Acronym
Effect of a wearable chair on surgeon strain and fatigue during laparoscopic inguinal hernia repair: an open-label randomized controlled pilot study.
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a wearable chair in reducing physical and mental strain on surgeons during laparoscopic inguinal hernia repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The surgeon's mental strain during surgery, assessed using heart rate variability.
Key secondary outcomes
subjective sensations measured on a 10-cm visual analog scale (VAS), operative duration, intraoperative blood loss, size of mesh used for repair, length of postoperative hospital stay and incidence of complications up to one month.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearable chair group
Interventions/Control_2
Non-wearable chair group
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants were adults with a diagnosis of inguinal hernia, admitted for elective repair at Hitachiomiya Saiseikai Hospital in Japan.
Key exclusion criteria
Key exclusion criteria are as follows
Requiring anterior approach surgery
Bilateral inguinal hernia
History of lower abdominal surgery
Presence of mesh at the surgical site
Liver disease with ascites
End-stage renal disease
BMI>=25.0 kg/m2
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Shinohara |
Organization
Jichi Medical University
Division name
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery
Zip code
3290498
Address
3311-1 Yakushiji, shimotsuke-shi, Tochigi, Japan
TEL
0285442111
m07045ss@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Shinohara |
Organization
Hitachiomiya Saiseikai Hospital
Division name
Department of Surgery
Zip code
3192256
Address
3033-3 Tagonai-cho, Hitachiomiya City, Ibaraki, Japan
TEL
0285442111
Homepage URL
m07045ss@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Shoichi Shinohara
Funding Source
Organization
Jichi Medical University
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
The Institutional Ethics Committee of Hitachiomiya Saiseikai Hospital
Address
3033-3 Tagonai-cho, Hitachiomiya City, Ibaraki, Japan
Tel
0295525151
m07045ss@jichi.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | 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
15
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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066230
