The HELI pilot: clinical research to investigate the possibility of fixation of the polypropylene mesh with autologous growth factor fibrin glue in hernia inguinalis surgery.

Hernia inguinalis is a rather common disorder mostly seen at men. Since several
years, the use of a polypropylene mesh during hernia surgery has become
standard, since it results in reducing the recurrence rate significantly.
With reducing the recurrence rate, the frequent appearance of chronic pain
after the surgery has become more prominent and therefor at this point the
biggest concern of this type of surgery. One of the possible causes is damage
of the local nerves by the use of sutures for fixation of the mesh. Therefor,
alternatives for fixation of the mesh are being investigated.
Several publications indicate Tissuecol (a commercial fibrin glue) to be a
promising option for fixation od the mesh at which the chronic pain indeed was
diminidhed and the recurrence rate still was low. The published studies are
rather small and have a short follow-up. Upon that, Tissuecol has some
disadvantages related to the fact that it contains foreign components (e.g.
allergy, coagulation disturbances, costs). Autologous growth factors fibrin
glue (AGW) seems to be an attractive alternative. AGW is being prepared out of
blood from the patient and contains fibrinogen (taking care of the acute
fixation of the mesh) and autologous growth factors (support ingrowth of the
mesh and therefor the definite fixation). AGW is being used successfully for
several other medical applications concerning fixation.
In the near future, a clinical trial will be performed, comparing chronic pain
post operatively between patients with fixation of the mesh by sutures and
patients with fixation of the mesh by AGW. Before a bigger group of patients
can be included in such a trial, it must be indisputable that AGW can provide
indeed the needed fixation of the mesh, with the normal recurrence rate. This
item is being investigated in the protocol HELI-pilot, at which in total 20
patiënts with a hernia inguinalis will be operated upon using AGW for fixation
of the mesh.
The most important outcome parameter is the recurrence rate. The maximum
acceptabel recurrence rate is 10% after 3 months. Secundary, the occurrence of
pain after the operation will be scored.

Using AGW gives a good fixation of the polypropylene mesh in hernia inguinalis
surgery and will not lead to a higher recurrence rate. The maximum acceptable
recurrence rate is 10% after 3 months.

• Patiënts who meet the inclusion criteria are informed on the study at the
outpatients' clinic and after signing the informed consent patiënts are
assigned to the waiting list.
• Preoperatively blood samples are taken and the AGW is prepared.
• The operations are performing following the protocol (appendix B). One of the
surgeons from the project team will be present at the operation to diminisg the
chance that recurrences occurr due to methodological reasons.
• All patiënts will be seen (post operatively) at the outpatients' clinic by
one of the surgeons from the project team.
• Patiënts will visit the outpatients' clinic after 2 weeks and after 3 months
for cchekcup. With more than 2 recurrences after 3 months, the pilot study is
judged unsuccessful and will be stopped immediately.
• Patiënts complete a short questionnaire on day 1 after surgery, day 14 after
surgery and 3 months after surgery.

Surgery of the hernia inguinalis following the Lichtenstein procedure, at which
AGW is used for fixation of the macroporous polypropyleen mesh.

• Pre-operatively two samples of 53 ml blood is taken for preparation of the
AGW.
• One surplus visit at the outpatients' clinic after 2 weeks (to detect
properly early recurrences).
• The visit to the outpatients' clinic after 3 months is a standard procedure
after hernia inguinalis surgery.