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Completed

NCT Number: NCT03734224

Inguinal Hernia Operation and Postoperative Pain

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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Key information

Conditions

Pain, Postoperative Hernia Hernia, Abdominal Hernia, Inguinal Inguinal Hernia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University hospital, Jorvi hospital

Espoo, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adhesix mesh

Procedure

Adhesix mesh

Progrip mesh

Procedure

Progrip mesh

Primary outcomes

  1. Number of contacts due to postoperative pain

    Time frame: 3 months

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

Secondary outcomes

  1. The use of pain medication

    Time frame: 1 year

    The use of painkillers postoperatively

  2. Pain intensity

    Time frame: 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")

  3. Number of contacts

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2018
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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