UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061226 |
|---|---|
| Receipt number | R000069968 |
| Scientific Title | A Prospective Cohort Study on Postoperative Bleeding Complications Following Inguinal Hernia Repair Under Continued Antiplatelet Therapy |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/10 15:02:52 |
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Basic information
Public title
A Prospective Cohort Study on the Incidence of Postoperative Bleeding Complications in Inguinal Hernia Repair Under Antiplatelet Therapy
Acronym
Safety of Hernia Surgery under Antiplatelet Therapy
Scientific Title
A Prospective Cohort Study on Postoperative Bleeding Complications Following Inguinal Hernia Repair Under Continued Antiplatelet Therapy
Scientific Title:Acronym
Bleeding Risk in Antiplatelet Inguinal Hernia Repair
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of postoperative hemorrhagic complications in adult patients undergoing inguinal hernia repair while continuing antiplatelet therapy.
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence and severity of postoperative hemorrhagic complications, as well as their impact on pain and quality of life (QOL), in patients undergoing surgery under continued antiplatelet therapy through a prospective study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative hemorrhagic complications within 30 days after surgery
Key secondary outcomes
Severity of hemorrhagic complications (Clavien-Dindo classification)
Distribution of subcutaneous hematoma
Pain and QOL scores (Brief Pain Inventory)
Perioperative data (Operative time, intraoperative blood loss, length of stay)
Other postoperative complications (SSI, Seroma, Mesh infection, Recurrence, Chronic pain)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older.
Patients scheduled for unilateral or bilateral inguinal hernia repair.
Patients currently receiving antiplatelet therapy (including dual or multiple antiplatelet therapy).
Key exclusion criteria
Emergency surgical cases (e.g., incarcerated hernia).
Patients with known bleeding disorders or coagulation abnormalities.
Patients receiving anticoagulant therapy (e.g., Warfarin, DOACs) or those receiving a combination of antiplatelet and anticoagulant therapy.
Patients undergoing robot-assisted inguinal hernia repair.
Patients judged unsuitable for the study by the attending physician or investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chikaraishi |
| Middle name | |
| Last name | Kentaro |
Organization
The Jikei University School of Medicine
Division name
Surgery
Zip code
105-0003
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
sakatadaisuke11@gmail.com
Public contact
Name of contact person
| 1st name | Chikaraishi |
| Middle name | |
| Last name | Kentaro |
Organization
The Jikei University School of Medicine
Division name
Surgery
Zip code
105-0003
Address
3-19-18 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
sakatadaisuke11@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
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
Institutional Review Board of The Jikei University School of Medicine
Address
3-19-18 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
| 2026 | Year | 05 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Evaluation Schedule & Medication
Assessment: POD 1, POD 14 , and POD 30 .
Medication Management: Preoperative withdrawal follows the Safety Management Manual. Oral medications resume on POD 1.
2. Endpoints
Primary: Incidence of hemorrhagic complications within 30 days postoperatively.
Secondary: * Severity and distribution of hematoma.
BPI (Brief Pain Inventory) scores for pain/QOL.
Intraoperative blood loss and operative time.
Length of stay and readmission.
Other complications (SSI, seroma, mesh infection, recurrence, chronic pain) via Clavien-Dindo Classification.
3. Severity of Hemorrhagic Complications
(Modified Clavien-Dindo Classification)
Grade Definition
0 None
1A Bleeding/hematoma requiring observation only.
1B Bleeding/hematoma requiring intervention (analgesics, compression).
2 Bleeding/hematoma requiring medication (hemostatics, iron) or transfusion.
3 Bleeding/hematoma requiring surgical intervention (e.g., evacuation).
4. Distribution of Subcutaneous Hematoma
Defined by the area bounded by the inguinal ligament, ASIS, and rectus abdominis:
Grade 1: Within the area; non-palpable.
Grade 2: Within the area; palpable.
Grade 3: Extending beyond the area (e.g., to the scrotum or back).
5. Pain and QOL Assessment
The BPI questionnaire will be administered during bleeding assessments. Questionnaires are to be distributed and collected on the same day.
Management information
Registered date
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069968
