JRCT ID: jRCT1071230076
Registered date:17/10/2023
Clinical study of inguinal hernia mesh fixation with fibrin glue
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | inguinal hernia |
Date of first enrollment | 05/10/2023 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | Early recurrence (recurrence within 3 months after surgery) |
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Secondary Outcome | Postoperative pain (VAS), hematoma/seroma development, mesh fixation time |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | |
Include criteria | (1) Patients undergoing hernia repair by TEP who wish to undergo hernia mesh fixation using fibrin glue. (2) Patients who are at least 20 years of age at the time of consent (3) Patients who fully understand this research plan and can give written consent. |
Exclude criteria | (1) Patients with a history of hypersensitivity to components of fibrin glue or drugs made from bovine lung (e.g. aprotinin) (due to contraindication to fibrin glue) (2) Patients undergoing treatment with coagulation accelerators (snake venom preparations) or antifibrinolytic agents (because of contraindications to the use of fibrin glue) (3) Other patients whom the investigator deems inappropriate as research subjects. |
Related Information
Primary Sponsor | TOMA Hiroki |
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Secondary Sponsor | |
Source(s) of Monetary Support | KM Biologics Co.,Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Hiroki TOMA |
Address | 1-8 Taihakumachi Hakataku Fukuoka 812-0033 Japan Fukuoka Japan 812-0033 |
Telephone | +81-92-291-3434 |
toma@surg1.med.kyushu-u.ac.jp | |
Affiliation | HARASANSHIN Hospital |
Scientific contact | |
Name | Hiroki TOMA |
Address | 1-8 Taihakumachi Hakataku Fukuoka 812-0033 Japan Fukuoka Japan 812-0033 |
Telephone | +81-92-291-3434 |
toma@surg1.med.kyushu-u.ac.jp | |
Affiliation | HARASANSHIN Hospital |