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

• ClinicalTrials.gov Identifier: NCT05091853
• Recruitment Status: Active, not recruiting
• First Posted: October 25, 2021
• Last Update Posted: March 13, 2024
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Anna-Maria Thölix, Helsinki University Central Hospital

Tracking Information

• First Submitted Date: October 13, 2021
• First Posted Date: October 25, 2021
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: May 9, 2021
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 13, 2021)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
• Official Title: Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
• Brief Summary: Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Treatment

Condition

• Inguinal Hernia
• Surgery

Intervention

Device: Adhesix mesh

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

Other Name: Progrip mesh

Study Arms

• Active Comparator: Self-adhesive mesh
  Intervention: Device: Adhesix mesh
• Active Comparator: Self-gripping mesh
  Intervention: Device: Adhesix mesh

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 13, 2021): 164
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT05091853
• Other Study ID Numbers: HUS/3413/2020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Anna-Maria Thölix, Helsinki University Central Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Helsinki University Central Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Helsinki University Central Hospital
• Verification Date: March 2024