Study protocol for a randomised clinical trial comparing TREPP versus Lichtenstein*s technique in Inguinal hernia patients

The main postoperative complication of inguinal hernia surgery has become
chronic postoperative inguinal pain (CPIP), especially present after the
Lichtenstein procedure, which is to this day the preferred open technique in
the Netherlands and worldwide. New techniques aimed at lowering the percentage
of patients who develop CPIP are showing promising first results. One of the
conditions of a new technique is that it has to be easy to learn and teach. A
new procedure that most likely meets these criteria is the TREPP (transrectus
sheath preperitoneal) mesh repair. This sizeable randomized trial compares the
TREPP technique to the Lichtenstein's procedure. The TREPPoLi trial aims to
contribute to the question: *what*s best for patients with a clinically
evident, unilateral inguinal hernia, TREPP or Lichtenstein?*

To asses the hypothesis that chronic postoperative inguinal pain occurs less in
patients treated with the TREPP technique

TREPPoLi is a multicenter randomised clinical trial (ISRCTN14511362) comparing
TREPP versus Lichtenstein from the patients* perspective next to societal- and
hospital perspective. All consecutive patients with a primary unilateral
inguinal hernia, eligible for operation, will be invited to participate in the
trial. Patients will be randomly allocated to the TREPP mesh repair or to
Lichtenstein*s procedure in one of the participating expertise centers, after
written informed consent is obtained. The primary outcome measure will be
presence of chronic postoperative inguinal pain (CPIP) of the TREPP and
Lichtenstein patients, measured after 6 months. The total follow-up period is 1
year.

TREPP or Lichtenstein

Two extra visits to the outpatient department as well as multiple
questionnaires and physical examination.