Inguinal Hernia Operation and Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative Inguinal Hernia Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1: Adhesix

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

Group Type ACTIVE_COMPARATOR

Adhesix mesh

Intervention Type PROCEDURE

Adhesix mesh

Group 2: Progrip

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

Group Type ACTIVE_COMPARATOR

Progrip mesh

Intervention Type PROCEDURE

Progrip mesh

Interventions

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Adhesix mesh

Intervention Type PROCEDURE

Progrip mesh

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No