UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057244 |
|---|---|
| Receipt number | R000065401 |
| Scientific Title | Prospective Intervention Study on Surgical Stress Alleviation Through Selective Low Insufflation Pressure in Laparoscopic Groin Hernia Repair |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2026/03/02 09:23:27 |
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Basic information
Public title
Clinical Study on Reducing Surgical Stress by Adjusting Pressure Based on Abdominal Wall Firmness in Laparoscopic Groin Hernia Surgery
Acronym
Tailored pressure laparoscopic groin hernia repair study
Scientific Title
Prospective Intervention Study on Surgical Stress Alleviation Through Selective Low Insufflation Pressure in Laparoscopic Groin Hernia Repair
Scientific Title:Acronym
SALI-Lap Study
Region
| Japan |
Condition
Condition
Groin hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether selectively utilizing low-pressure pneumoperitoneum (6 mmHg) in high abdominal compliance patients can alleviate surgical stress compared to a historical control group that underwent surgery under standard pressure (8-10 mmHg).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOR-15 score on the day after surgery
Key secondary outcomes
intra-operative complications, conversion to standard pressure, VAS pain score on the day after surgery, analgesic use frequency, postoperative hospital stay, QOR-15 score on the first outpatient visit after discharge
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conduct surgery under low pressure (6 mmHg) in high abdominal compliance patients
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with inguinal hernia based on physical examination or imaging studies
2) Aged between 20 and 85 years
3) ECOG performance status (PS) of 0 to 2
4) No severe impairment of major organ function (heart, lungs, liver, kidneys)
5) Patients who have provided written informed consent, signed and dated, prior to enrollment in the study
Key exclusion criteria
1) Conversion to open surgery
2) Complicated hernias, including incarceration, strangulation, or large scrotal-type hernias
3) Deviation from standard TAPP (e.g., mini-laparotomy, additional trocars, modified IPOM)
4) Robot-assisted surgery
5) Patients who refuse or fail to complete the QOR questionnaire
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Kinoshita |
Organization
Yamatotakada Municipal Hospital
Division name
Dept. Surgery
Zip code
635-8501
Address
1-1 Isono Kitamachi, Yamatotakada, Nara, Japan
TEL
0745-53-2901
soi1214@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kinoshita |
Organization
Yamatotakada Municipal Hopital
Division name
Dept. Surgery
Zip code
635-8501
Address
1-1 Isono Kitamachi, Yamatotakada, Nara, Japan
TEL
0745-53-2901
Homepage URL
soi1214@naramed-u.ac.jp
Sponsor or person
Institute
Yamatotakada Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Yamatotakada Municipal Hopital Ethics Committee
Address
1-1 Isono Kitamachi, Yamatotakada, Nara, Japan
Tel
0745-53-2901
soumu@ym-hp.yamatotakada.nara.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 | 03 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2025 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065401
