Inguinal Hernia Operation and Postoperative Pain

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

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 Overview

• Status: Completed
• Conditions: Quality of Life; Pain, Postoperative; Inguinal Hernia
• Intervention / Treatment: Procedure: Adhesix mesh; Procedure: Progrip mesh

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Helsinki University Hospital, Jorvi hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group1: Adhesix; This group gets the Adhesix mesh in a normal open hernia operation.	Procedure: Adhesix mesh; Adhesix mesh
ACTIVE_COMPARATOR: Group 2: Progrip; This group gets the Progrip mesh in a normal open hernia operation.	Procedure: Progrip mesh; Progrip mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The use of pain medication	The use of painkillers postoperatively	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")	1 year
Number of contacts	Number of contacts to the operating unit/health care system due to pain after the operation	1 year

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (ACTUAL): November 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal
• Other Study ID Numbers: HUS-459-2018-61

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No