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MALE INFERTILITY AFTER TOTALLY EXTRAPERITONEAL (TEP) ENDOSCOPIC HERNIA REPAIR.


- candidate number7753
- NTR NumberNTR2208
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2010
- Secondary IDsNL30818.100.09 ABR
- Public TitleMALE INFERTILITY AFTER TOTALLY EXTRAPERITONEAL (TEP) ENDOSCOPIC HERNIA REPAIR.
- Scientific TitleMALE INFERTILITY AFTER TOTALLY EXTRAPERITONEAL (TEP) ENDOSCOPIC HERNIA REPAIR.
- ACRONYMMAIN studie
- hypothesisThe hypothesis is that a mesh used in Totally Extraperitoneal Endoscopic Hernia repair (TEP) has no effect on male fertility. The "0" hypothesis is that there is no difference in testicular perfusion (primary objective) before and after TEP and that there is no difference in testicular volume, semen quality and serum hormone levels (FSH, LH, inhibine B, testosterone).
- Healt Condition(s) or Problem(s) studiedInguinal hernia, Fertility, Mash, Totally Extraperitoneal (TEP) endoscopic hernia repair, Testicular perfusion
- Inclusion criteria1. Male patients, 18 years of age or older and younger than 60 years;
2. Patients with a primary, bilateral hernia;
3. Nyhus classification II or III.
- Exclusion criteria1. Male patients older than 60 years of age;
2. Nyhus classification I and IV;
3. Scrotal or femoral hernia's;
4. Hydrocele or varicocele;
5. Incarcerated hernia;
6. ASA classification III;
7. Previous medical history of:
A. Testicular infection(s), testicular torsion, cryptorchidism;
B. Inguinal, scrotal, testicular of prostate surgery;
C. Radiotherapy of pelvic region;
D. Diabetes;
E. Cystic Fibrosis;
F. Fertility problems and/or treatment, erection disorders or (other) problems in sexual function.
8. Use of gonadotrofine medication;
9. Use of anabolic steroids.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate31-jul-2012
- Target number of participants76
- Interventions1. 2x blood analysis: FSH, LH, testosterone and Inhibin B;
2. 2x sperm analysis;
3. 2x Testicular ultrasound (perfusion and volume).

All parameters are evaluated before surgery and 6 months after surgery.
- Primary outcomeTesticular perfusion after a Totally ExtraPeritoneal (TEP) endoscopic hernia repair.
- Secondary outcome1. Testicular volume after TEP;
2. Sperm quality and quantity after TEP;
3. FSH, LH, testosteron and inhibin B serum levels.
- Timepoints1. Before surgery (baseline);
2. 6 months after surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. N. Schouten
- CONTACT for SCIENTIFIC QUERIESDrs. N. Schouten
- Sponsor/Initiator Diakonessenhuis Zeist
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Diakonessenhuis (SWODU)
- PublicationsN/A
- Brief summaryDue 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 who undergo (Totally Extraperitoneal endoscopic) hernia surgery.
In this study parameters of male fertility, as testicular perfusion and volume, sperm quality and hormone levels in blood, will be evaluated before and 6 months after TEP hernia surgery.
- Main changes (audit trail)
- RECORD11-feb-2010 - 12-mrt-2010


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