Pain Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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