The influence of laparoscopic hernia repair on male fertility

Groin herniorrhaphy is the most common operation performed by general surgeons.
Annually over 20 million groin hernias are repaired worldwide. In the
Netherlands 30,000 groin hernia repairs are done annually. The lifetime risk of
developing a groin hernia is 3% in males. Symptoms of a groin hernia are pain,
discomfort or cosmetic complaints.
There are many different techniques to repair a groin hernia. The
conventional technique is the open suture technique. The skin is opened, the
hernia is reduced and primarily closed. Recurrence rates after suture repair
have been reported as high as 40%. In the 1970s Lichtenstein introduced the
open tension-free repair, utilizing mesh to reinforce the posterior wall of the
inguinal canal. He reported a recurrence rate that was as low as 0.7%. Due to
this low recurrence rate, this technique gained much popularity, and it is
until this day regarded as the golden standard. In the early 1990s laparoscopic
techniques were introduced for groin hernia repair. With this technique three
small incisions are made. Through a posterior approach the posterior wall of
the inguinal canal is reinforced by mesh. The recurrence rates after
laparoscopic repair found in the literature are much alike open tension-free
mesh repair.
This mesh is positioned close by the funiculus spermaticus. Through the
funiculus spermaticus runs the spermatic cord. The foreign body (mesh) induces
a foreign body response of structures closely positioned to this mesh, such as
the funiculus spermaticus, resulting in scar tissue. This response is a key
element of the reinforcement of the posterior wall of the inguinal canal. The
effect of this foreign body response and scar tissue on the fertility in males
however, is unknown. Literature shows that testicular volume, testicular
perfusion and diameter of the lumen of the vas deferens decrease. Also, due to
the foreign body response of the funiculus spermaticus the blood-testis barrier
is damaged. This may result in the generation of antisperm antibodies. These
antibodies influence the male fertility.
If this pilot shows the presence of antisperm antibodies after
laparoscopic inguinal hernia repair, we will continue researching the presence
of antibodies after different techniques, such as the open tension-free mesh
repair technique. The results of this pilot study will therefore influence the
general recommendations in techniques used in fertile men with a groin hernia.

This study is a pilot study to examine the presence of antisperm antibodies
after laparoscopic groin hernia repair in men.
The hypothesis of this pilot study is: After laparoscopic groin hernia repair
with a mesh, antisperm antibodies can be detected in semen.

Operation technique: the inguinal hernia will be repaired laparoscopically by
either the TEP or the TAPP technique. The repair will be done under general
anaesthesia. Three small incisions will be made in the abdomen, to introduce
the instruments. During the TEP technique all the instruments will remain
outside the abdominal cavity, but in the preperitoneal space. The instrument
will create space towards the inguinal canal in such a way that the peritoneum
will remain closed. The inguinal hernia will be reduced and a mesh will be
positioned to increase the strength of the posterior wall of the inguinal
canal. During the TAPP technique the instruments will be introduces in the
abdominal cavity. The peritoneum will be opened, and the same preperitoneal
space will be entered. The hernia will be reduced and the mesh will be
positioned. After positioning of the mesh, the peritoneum will be closed by a
suture. The results of the TEP and TAPP technique are comparable.

Semen analysis: The semen analysis will be done several days prior to surgery
and 6 months after surgery. The patient will produce the semenmonster and
deliver it to the Clinical Laboratory at the Slotervaartziekenhuis. The quality
of the semen will be analyzed according to the WHO-criteria (see secondary
outcomes) and the presence of antisperm antibodies will be evaluated. These
antibodies will be detected by the SperMar test. During this test a reagens
will be applied to the sperm cells. This reagens attaches to possible antisperm
antibodies and antisperm antibodies can be made visible. When the second
SperMar test shows presence of antisperm antibodies, the patient will be
requested to produce a third semenmonster. This semenmonster will also be
produced at home, and delivered at the IVF-centre of the VU Medical Centre. In
the VU Medical Centre the Immunobead test will be done. In this test also, a
reagens will be applied to the sperm cells. This reagens shows the presence of
antisperm antibodies and also the type of antibodies

Power-analysis: In the pre-operative semen analysis no presence of antisperm
antibodies is expected. The possible risk factors that may initiate the
presence of antibodies, like scrotal trauma or immunodepression, are used as
exclusion criteria. We would like to estimate a difference of 10% between the
pre-operative and post-operative semen analysis with α = 0.05 and power = 0.8.
We therefore need approximately 80 patients.

Statistical analysis: to estimate the difference in presence of antisperm
antibodies a chi-square test will be used.

Semen production: The patient should abstain himself from ejaculation in the
three days prior to producing the semenmonster. The semenmonster is supposed to
be produced by masturbation. To guarantee the highest possible quality of the
semenmonster, the following guidelines need to be considered:
• The patient needs to empty his bladder before masturbation. He needs to rinse
his penis with water, but not with soap. The penis should dried by shaking of
the water (not by drying it with a towel).
• The semen will be damaged by sudden drop in temperature. The jar needs to be
pre-heated to room temperature by holding the jar in the hands, or by putting
the jar in pocket.
• The total amount of sperm needs to be caught in the jar. The inside of the
jar is sterile and is not supposed to be touched by the fingers.
• The jar needs to be firmly closed by the lid.
• During transportation to the hospital sudden drop in temperature needs to be
avoided. The jar needs to be wrapped by aluminium foil and kept close to body
heat during winter. The jar containing the sperm needs to be delivered within 1
hour at the Clinical Laboratory at the Slotervaartziekenhuis.

In case of presence of antibodies in the second semen analysis, a third semen
analysis needs to be done at the VU Medical Centre. The semenmonster needs to
be produced at home, in the same way as described above. The semenmonster needs
to be delivered within two hours at the IVF-centre at the VU Medical Centre.

Inclusion criteria:
• Primary inguinal hernia
• Male gender
• Age > 18 years
• Elective surgery
• Informed consent
• Both testes descended

Exclusion criteria
• Fertility problems in past history
• Scrotal trauma
• Surgery in groin area in past history
• Immune depression
• Severe comorbidity
• Palpable lesion in scrotum

not applicable