Inguinal Hernia Operation and Postoperative Pain

Not Applicable

Completed

• Conditions: Pain, Postoperative; Quality of Life; Inguinal Hernia
• Interventions: Procedure: Adhesix mesh; Procedure: Progrip mesh

• Registration Number: NCT03734224
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-27
• Study Start: 2018-11-01
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1: Adhesix	Adhesix mesh	This group gets the Adhesix mesh in a normal open hernia operation.
Group 2: Progrip	Progrip mesh	This group gets the Progrip mesh in a normal open hernia operation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The use of pain medication	1 year	The use of painkillers postoperatively
Pain intensity	1 year	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")
Number of contacts	1 year	Number of contacts to the operating unit/health care system due to pain after the operation

Trial Locations

Locations (1)

Helsinki University hospital, Jorvi hospital; 🇫🇮 Espoo, Finland