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

June 5, 2015 updated by: University of Aarhus

A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midt
      • Viborg, Region Midt, Denmark, 8800
        • Recruiting
        • Hospitalsenheden Midt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-fixating mesh
During surgery, the Parietex ProGrib mesh will be used.
Device: Parietex ProGrib self-fixating mesh
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.
Active Comparator: Tack fixation
During surgery, the mesh will be fixated with tacks.
Device: Tack fixation
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients experiencing acute postoperative pain, using the NRS pain score.
Time Frame: 3 months
3 months
Number of patients with recurrent hernia.
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Medtronic - MITG

Investigators

  • Study Director: Michael F Nielsen, MD PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2307PG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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