Inguinal Hernia Operation and Postoperative Pain

Helsinki University Central Hospital270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Pain, Postoperative Inguinal Hernia Quality of Life

Interventions

Adhesix meshPROCEDURE

Adhesix mesh

Progrip meshPROCEDURE

Progrip mesh

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University hospital, Jorvi hospital

Espoo, Finland

Outcomes

Primary Outcomes

Number of contacts due to postoperative pain

Number of postoperative contacts to the operating unit due to pain at 3 months after the operation

Time frame: 3 months

Secondary Outcomes

The use of pain medication

The use of painkillers postoperatively

Time frame: 1 year

Pain intensity

The pain intensity at the Numeric Pain Rating Scale (NPRS), where the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine")

Time frame: 1 year

Number of contacts

Number of contacts to the operating unit/health care system due to pain after the operation

Time frame: 1 year

Data from ClinicalTrials.gov

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