Inguinal Hernia Operation and Postoperative Pain

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Quality of Life; Pain, Postoperative; Inguinal Hernia

Treatments: Procedure: Progrip mesh; Procedure: Adhesix mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03734224

HUS-459-2018-61

Details and patient eligibility

About

Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.

Enrollment: 270 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.

Exclusion criteria

• female
• bilateral hernia
• Incarcerated hernia
• Scrotal hernia
• ASA-classification >3
• BMI >35 or <18
• No hernia found in clinical examination
• Liver cirrhosis
• Other contraindication for inguinal hernia operation
• Anticoagulant therapy, that needs bridge therapy when paused

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Group1: Adhesix

Active Comparator group

Description:

This group gets the Adhesix mesh in a normal open hernia operation.

Treatment:

Procedure: Adhesix mesh

Group 2: Progrip

Active Comparator group

Description:

This group gets the Progrip mesh in a normal open hernia operation.

Treatment:

Procedure: Progrip mesh