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

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Surgery; Inguinal Hernia

Treatments: Device: Adhesix mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT05091853

HUS/3413/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Self-adhesive mesh

Active Comparator group

Treatment:

Device: Adhesix mesh

Self-gripping mesh

Active Comparator group

Treatment:

Device: Adhesix mesh