Clinical study of inguinal hernia mesh fixation with fibrin glue

JRCT ID: jRCT1071230076

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: inguinal hernia
• Date of first enrollment: 05/10/2023
• Target sample size: 20
• Study type: Observational

Outcome(s)

• Primary Outcome: Early recurrence (recurrence within 3 months after surgery)
• Secondary Outcome: Postoperative pain (VAS), hematoma/seroma development, mesh fixation time

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

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
• Source(s) of Monetary Support: KM Biologics Co.,Ltd.