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

NCT ID: NCT02467140

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-31

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.

Conditions

Inguinal Hernia; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-fixating mesh

During surgery, the Parietex ProGrib mesh will be used.

Group Type: ACTIVE_COMPARATOR

Parietex ProGrib self-fixating mesh

Intervention Type: DEVICE

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.

Tack fixation

During surgery, the mesh will be fixated with tacks.

Group Type: ACTIVE_COMPARATOR

Tack fixation

Intervention Type: DEVICE

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.

Interventions

Parietex ProGrib self-fixating mesh

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.

Intervention Type: DEVICE

Tack fixation

Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Nielsen, MD PhD

Role: STUDY_DIRECTOR

Locations

Hospitalsenheden Midt

Viborg, Region Midt, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Malene O Dinesen, MD PhD

Role: CONTACT

maledine@rm.dk

+45 42 29 00 23

Marie K Christensen, MD

Role: CONTACT

mariekirk@dadlnet.dk

+45 40 79 54 59

Other Identifiers

2307PG

Identifier Type: -

Identifier Source: org_study_id