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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091853
Recruitment Status : Active, not recruiting
First Posted : October 25, 2021
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Anna-Maria Thölix, Helsinki University Central Hospital

Study Description
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Brief Summary:
Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

Condition or disease Intervention/treatment Phase
Inguinal Hernia Surgery Device: Adhesix mesh Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
Actual Study Start Date : May 9, 2021
Actual Primary Completion Date : July 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Self-adhesive mesh Device: Adhesix mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
Other Name: Progrip mesh
Active Comparator: Self-gripping mesh Device: Adhesix mesh
2 meshes are used; the self-gripping Progrip mesh and the self-adhesive Adhesix mesh
Other Name: Progrip mesh


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05091853


Locations
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Finland
Helsinki ja uudenmaan sairaalhoitopiiri
Espoo, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
More Information
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Responsible Party: Anna-Maria Thölix, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT05091853    
Other Study ID Numbers: HUS/3413/2020
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal