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

Not Applicable

• Conditions: Inguinal Hernia; Pain
• Interventions: Device: Tack fixation; Device: Parietex ProGrib self-fixating mesh

• Registration Number: NCT02467140
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Study First Posted: 2015-06-09
• Last Update Posted: 2015-06-09
• Primary Completion: 2016-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tack fixation	Tack fixation	During surgery, the mesh will be fixated with tacks.
Self-fixating mesh	Parietex ProGrib self-fixating mesh	During surgery, the Parietex ProGrib mesh will be used.

Primary Outcome Measures

Name	Time	Method
Number of patients with recurrent hernia.	1 year
Number of patients experiencing acute postoperative pain, using the NRS pain score.	3 months

Secondary Outcome Measures

Name	Time	Method
Number of patients experiencing chronic postoperative pain, using the NRS pain score.	1 year
Quality of life before and after surgery, using the Carolina Comfort Scale	6 months

Trial Locations

Locations (1)

Hospitalsenheden Midt; 🇩🇰 Viborg, Region Midt, Denmark