Clinical evaluation of postoperative quality-of-life in the open mesh repair for inguinal hernia

UMIN ID: UMIN000000946

Registered date:14/12/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Inguinal hernia
• Date of first enrollment: 2008/01/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

PROLENE* Hernia System (sterilized by EO sterilizing) for herniorraphy. Approved Number; 20400BZY00787000
BARD mesh (plug) (sterilized by EO sterilizing) for herniorraphy. Approved Number; 16000BZY01128000

Outcome(s)

• Primary Outcome: Comparison study of quality-of-life in the patients 1, 3, 6 and 12 month after the operation using SF-36.
• Secondary Outcome: Comparison study of postoperative pain (1, 2, 3, 7 day and 1, 3, 6, 12 month after the operation), complication and recurrence.

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Pregnant 2. The case with pneumonitis, peritonitis, ileus, perforation, intraperitoneally infection or urinary infection. 3. The case with Bleed, clotting disorder, wound healing disorder. 4. The case with mental illness such as depression and dementia. 5. Relapsing hernia 6. Incarcerated hernia which cannot be reduced. 7. The case with peripheral nerve disorder.

Related Information

• Primary Sponsor: Showa university fujigaoka hospital Surgery, 1-30, fujigaoka, aoba-ku, yokohama-city, kanagawa, Japan
• Source(s) of Monetary Support: none