Clinical trial NCT02467140: Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation
Official title: A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Pain
Keywords: Inguinal hernia repair
Hernia
ProGrib self-fixating mesh
Biological mesh
Tack fixation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2015-06-09
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients experiencing acute postoperative pain, using the NRS pain score.
timeFrame: 3 months
measure: Number of patients with recurrent hernia.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients experiencing chronic postoperative pain, using the NRS pain score.
timeFrame: 1 year
measure: Quality of life before and after surgery, using the Carolina Comfort Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Hospitalsenheden Midt
state: Region Midt
Study officials:
name: Michael F Nielsen, MD PhD
role: STUDY_DIRECTOR
References: