The 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…
ID
Bron
Verkorte titel
Aandoening
Engels:
- inguinal hernia
- Totally Extraperitoneal (TEP) endoscopic hernia repair
- mesh
- fertility
- testicular perfusion
Nederlands:
- liesbreuk
- matje
- Totaal Extraperitoneale (TEP) laparoscopische liesbreukcorrectie
- Fertiliteit
- testiculaire perfusie
Ondersteuning
Prof. Lorentzlaan 37,
3707 HL Zeist
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Testicular perfusion after a Totally ExtraPeritoneal (TEP) endoscopic hernia repair.
Achtergrond van het onderzoek
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 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.
Doel van het onderzoek
The 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).
Onderzoeksopzet
1. Before surgery (baseline);
2. 6 months after surgery.
Onderzoeksproduct en/of interventie
1. 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.
Publiek
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
Wetenschappelijk
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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 ¡Ý 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2091 |
| NTR-old | NTR2208 |
| CCMO | NL30818.100.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38181 |