Is fixation of mesh necessary during laparoscopic transabdominal preperitoneal repair? Randomized controlled trial (TAPP-MEISTER Trial)

UMIN ID: UMIN000054210

Registered date:01/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Inguinal hernia
• Date of first enrollment: 2024/06/01
• Target sample size: 1600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Mesh fixation using tackerixation using tacker
No mesh fixation

Outcome(s)

• Primary Outcome: Recurrence rate at 1 year after TAPP
• Secondary Outcome: Duration of Surgery, Intra- and postoperative complication, The strongest pain intensity, pain intensity at rest, and pain intensity during daily life at 1 year after TAPP, Discomfortable sensation, Paresthesia, Ejaculation pain, Erection pain, Duration between surgery and getting back to the normal living, risk factors associated with pain at 1 year after TAPP

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients having L3 or M3 hernia according to the EHS guidelines 2) Patients planned to undergo surgery for chronic pain or recurrece 3) Patients with postoperative status of radical prostatectomy 4) Patients planned to undergo surgery for bilateral inguinal hernia 5) Patients planned to undergo surgery for femoral hernia 6) Patients planned to undergo surgery for concomitant surgery for another disease 7) Patients who are deemed to be an inappropriate case to participate in the present trial by their doctor

Related Information

• Primary Sponsor: Kobe City Medical Center General Hospital
• Source(s) of Monetary Support: self-procured