Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation

University of Aarhus

Status: Unknown

Conditions: Inguinal Hernia; Pain

Treatments: Device: Parietex ProGrib self-fixating mesh; Device: Tack fixation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02467140

2307PG

Details and patient eligibility

About

A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.

Full description

The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.

Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .

The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.

After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.

The participating patients will receive postoperative questionnaires following the first year after surgery.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective, inguinal hernia repair
• 18 years or older
• Male gender
• ASA physical classification system 1-3
• Informed consent

Exclusion criteria

• Patients with recurrent hernia, except patients operated in childhood without mesh application.
• Patients with bilateral hernia
• Patients with chronic pain
• Patients in anticoagulation therapy
• Previous major surgery in lower abdomen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Self-fixating mesh

Active Comparator group

Description:

During surgery, the Parietex ProGrib mesh will be used.

Treatment:

Device: Parietex ProGrib self-fixating mesh

Tack fixation

Active Comparator group

Description:

During surgery, the mesh will be fixated with tacks.

Treatment:

Device: Tack fixation