Inguinal Hernia Operation and Postoperative Pain

Quality of Life Clinical Trial

Official title:

Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734224
• Other study ID #: HUS-459-2018-61
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Postoperative
• Quality of Life

Intervention

Procedure:
• Adhesix mesh
Adhesix mesh
• Progrip mesh
Progrip mesh

Locations

Country	Name	City	State
Finland	Helsinki University hospital, Jorvi hospital	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of contacts due to postoperative pain	Number of postoperative contacts to the operating unit due to pain at 3 months after the operation	3 months
Secondary	The use of pain medication	The use of painkillers postoperatively	1 year
Secondary	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")	1 year
Secondary	Number of contacts	Number of contacts to the operating unit/health care system due to pain after the operation	1 year