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Open Access Study protocol

Male infertility after endoscopic Totally Extraperitoneal (Tep) hernia repair (Main): rationale and design of a prospective observational cohort study

Nelleke Schouten16*, Thijs van Dalen1, Niels Smakman1, Sjoerd G Elias2, Cees van de Water3, Roan J Spermon4, Laurens Sibinga Mulder5 and Ine P J Burgmans1

Author affiliations

1 Department of Surgery/Hernia Clinic, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands

2 Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands

3 Department of Laboratory, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands

4 Department of Urology, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands

5 Department of Radiology, Diakonessenhuis Utrecht/Zeist, Utrecht, The Netherlands

6 Department of Surgery, Diakonessenhuis, Professor Lorentzlaan 76, 3707, HL, Zeist, The Netherlands

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Citation and License

BMC Surgery 2012, 12:7  doi:10.1186/1471-2482-12-7

Published: 21 May 2012

Abstract

Background

To describe the rationale and design of an observational cohort study analyzing the effects of endoscopic Totally Extraperitoneal (TEP) hernia repair on male fertility (MAIN study).

Methods and design

The MAIN study is an observational cohort study designed to assess fertility after endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specialized in TEP hernia repair. Male patients of 18-60 years of age, with primary, reducible, bilateral inguinal hernias and no contraindications for endoscopic TEP repair are eligible for inclusion in this study. Patients with an ASA-classification ≥ III and patients with recurrent and/or scrotal hernias and/or a medical history of pelvic surgery and/or radiotherapy, known fertility problems, diabetes and/or other diseases associated with a risk of fertility problems, will be excluded. The primary outcome is the testicular perfusion before and 6 months after TEP hernia repair (assessed by means of a scrotal ultrasonography). Secondary endpoints are the testicular volume (Ultrasound), semen quality and quantity and the endocrinological status, based on serum levels of the sexual hormones follicle-stimulating hormone (FSH), luteinizing hormone (LSH), testosterone and inhibin B before and 6 months after TEP hernia repair.

Discussion

The use of polypropylene mesh is associated with a strong foreign body reaction which could play a role in chronic groin pain development. Since the mesh in (endoscopic) inguinal hernia repair is placed in close contact to the vas deferens and spermatic vessels, the mesh-induced inflammatory reaction could lead to a dysfunction of these structures. Relevant large and prospective clinical studies on the problem are limited. This study will provide a complete assessment of fertility in male patients who undergo simultaneous bilateral endoscopic TEP hernia repair, by analyzing testicular perfusion and volume, semen quantity and quality and endocrinological status before and 6 months after TEP repair.

Trial registration

The MAIN study is registered in the Dutch Trial Register (NTR2208)