The primary aim of this study is to examine/determine the effect of Totally ExtraPeritoneal (TEP) endoscopic hernia repair on male fertility. To measure this outcome, we examine testicular perfusion, volume, semen quality and blood levels of…
ID
Source
Brief title
Condition
- Other condition
- Sexual function and fertility disorders
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
liesbreuken en endoscopische liesbreukoperaties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Testicular perfusion after a Totally ExtraPeritoneal (TEP) endoscopic hernia
repair.
Secondary outcome
- Testicular volume after TEP
- Sperm quality and quantity after TEP
- FSH, LH, testosteron and inhibin B serum levels
Background summary
Inguinal hernia repair (or herniorrhaphy) is the most frequently performed
operation in general surgery. Men have a lifelong risk of 27% to undergo
inguinal herniorrhaphy.
An estimated 80% of these hernia operations involve placement of a knitted
polypropylene monofilament mesh prosthesis to patch the defect in the floor of
the inguinal canal. Subsequently, the prosthetic mesh induces an acute
inflammatory reaction followed by a chronic foreign-body fibroblastic response
that creates scar tissue and imparts strength to the floor.
Due to the close contact between mesh and the structures of the spermatic cord,
these changes may also alter the reproductive structures - and therefore-
fertility in maile patients. One of the complications after hernia repair is
ischemic orchitis resulting in testicular infarction and atrophy. Another
reported complication is seminal tract obstruction resulting in obstructive
azoospermia.
Regardless of surgical technique, little clinical information is available
regarding the long-term effects of the polypropyleen mesh on the vas deferens
and other structures within the spermatic cord and therefore on fertility.
Parameters to measure fertility and function of reproductive structures are
sperm quality (and quantity), testicular perfusion and volume, serum hormones
(FSH, LH, testosteron, inhibine B).
In his prospective observational cohort study these parameters will be measured
before and 6 months after a TotallyExtraperitoneal Endoscopic hernia repair
(TEP). The primary aim of this study is to investigate the interaction between
mesh in TEP repair and male fertility.
Study objective
The primary aim of this study is to examine/determine the effect of Totally
ExtraPeritoneal (TEP) endoscopic hernia repair on male fertility. To measure
this outcome, we examine testicular perfusion, volume, semen quality and blood
levels of testosteron, LH, FSH, inhibin B (blood) levels after a TEP.
Study design
The study design is a longitudinal, observational, prospective cohort study
Study burden and risks
There are no additional risks associated with this observational study compared
to 'regular' hernia surgery and treatment. Peroperative and perioperative care
for patients who participate in this trial is also not different from regular
per- and perioperative care.
Postbus 1002
3700 BA Zeist
NL
Postbus 1002
3700 BA Zeist
NL
Listed location countries
Age
Inclusion criteria
- Male patients * 18 years of age
- With a primary, bilateral hernia inguinalis
- Male patients with an unilateral hernia inguinalis and ipsilateral mono-testicle
- Nyhus classification II and III
Exclusion criteria
- Male patients older than 60 years of age
- Nyhus classification I and IV
- Scrotal or femoral hernia's
- Hydrocele or varicocele
- Strangulated hernia
- ASA classification * III
- Previous medical history of:
* testicular infection(s), testicular torsion, cryptorchidism
* Inguinal, scrotal, testicular of prostate surgery
* Radiotherapy of pelvic region
* Diabetes/vasculitis
* Cystic Fibrosis
* Fertility problems and/or treatment and erection disorders
- Use of gonadotrofine medication
- Use of anabolic steroids
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | De trial is geregistreerd in het trialregister (trialregister.nl). Op dit moment is er nog geen definitief identificatienummer toegediend. Kandidaatnummer is NTR7753 |
| CCMO | NL30818.100.09 |
| OMON | NL-OMON29194 |