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OpenTrials
Completed

NCT Number: NCT05091853

Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?

Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki ja uudenmaan sairaalhoitopiiri

Espoo, Finland

About this study

Pain after inguinal hernia surgery is a major problem for the patient and results in lower quality of life. In this randomized clinical trial we examine if the choice of self-fixed mesh affects post-operative inguinal pain in laparoscopic hernia surgery. 164 patients are randomized and followed up for 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery

Exclusion criteria

  • scrotal or incarcerated hernia
  • previous laparotomy
  • ASA >3
  • BMI <18 or >35
  • Liver cirrhosis
  • No hernia in clinical examination

Treatment and study plan

Adhesix mesh

Device

2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh

Other names: Progrip mesh

Primary outcomes

  1. Pain during the first post-operative week

    Time frame: 1 year

    The degree of pain (VAS score) and the use of pain medication during the first postoperative week

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 25, 2021
Registry last updated
Oct 2, 2024

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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