Dataset Information

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

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).

SUBMITTER: Schouten N

PROVIDER: S-EPMC3414734 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

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Publications

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

Schouten Nelleke N van Dalen Thijs T Smakman Niels N Elias Sjoerd G SG van de Water Cees C Spermon Roan J RJ Mulder Laurens Sibinga LS Burgmans Ine P J IP

BMC surgery 20120521

<h4>Background</h4>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).<h4>Methods and design</h4>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 i ...[more]

PMID: 22612995

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Project description:BackgroundGroin pain is a frequent complaint in surgical practice with an inguinal hernia being at the top of the differential diagnosis. The majority of inguinal hernias can be diagnosed clinically. However, patients with groin pain without signs of an inguinal hernia on anamnesis or physical examination provide a diagnostic challenge. If ultrasonography shows a hernia that could not be detected clinically, this entity is called a clinically occult hernia. It is debatable if this radiological hernia is the cause of complaints in all patients with inguinal pain. The objective of this study is to assess whether watchful waiting is non-inferior to endoscopic totally extraperitoneal (TEP) inguinal repair in patients with a clinically occult inguinal hernia.MethodsThe EFFECT study is a multicenter non-blinded randomized controlled non-inferiority trial. Adult patients with unilateral groin pain and a clinically occult inguinal hernia are eligible to participate in this study. A total of 160 participants will be included and randomized to TEP inguinal hernia repair or a watchful waiting approach. The primary outcome of this study is pain reduction 3 months after treatment, measured by the Numeric Rating Scale (NRS). Secondary outcomes are quality of life, cost-effectiveness, patient satisfaction and crossover rate. Eight surgical centers will take part in the study. Participants will be followed-up for 1 year.DiscussionThis is the first large randomized controlled trial comparing treatments for patients with groin pain and a clinically occult inguinal hernia. To date, there are no interventional studies on the effect of surgery or a watchful waiting approach in terms of pain or quality of life in this subset of patients. A trial comparing the outcomes of the two approaches in patients with a clinically occult inguinal hernia is urgently needed to provide data facilitating the choice between the two treatment options. If watchful waiting is not inferior to surgical repair, costs of surgical repair may be saved.Trial registrationThe study protocol (NL61730.100.17) is approved by the Medical Ethics Committee (MEC-U) of the Diakonessenhuis, Utrecht, The Netherlands. The study was registered at the Netherlands Trial Registry ( NTR6835 ) registered on November 13, 2017.

Project description:BackgroundA congenital prepubic sinus (CPS) is a rare congenital anomaly in which a duct remnant extends from the skin opening near the pubic symphysis to various parts and the lesions are mostly located in the preperitoneal space. The totally extraperitoneal (TEP) approach is an operational method that provides a good field of view for the preperitoneal space. We report the CPS through the pubic symphysis in which complete resection was achieved by a TEP approach. TEP approach was minimally invasive and achieved satisfactory cosmetic outcome.Case presentationWe herein report the case of a 13-year-old boy with a fistula opening near the dorsal penis. He was admitted to our hospital due to fever and lower abdominal pain. Abdominal ultrasonography and computed tomography revealed an abscess inside a fistula lumen on the posterior surface of the rectus abdominis muscles in the midline of the lower abdomen. Under a diagnosis of CPS, which was located in the preperitoneal space, endoscopic resection was performed by a totally extraperitoneal approach. After making an umbilical incision, the rectus abdominis muscle was excised outward to expose the preperitoneal space. A single-port system was placed in the preperitoneal space. Three 5-mm-port trocars were inserted. As the preperitoneal cavity was expanded, a sinus connecting to the pubic symphysis was confirmed. The pubic symphysis did not connect with the bladder. Because the fistula was penetrated with the pubic symphysis, the remaining caudal fistula was removed from the body surface with a small spindle-shaped incision around the fistula opening. Finally, the sinus was completely resected, with confirmation from both the cranial side and dorsal side of the pubic symphysis. We were able to perform complete resection of the CPS with good visibility and without any peritoneal damage. There were no intraoperative complications. His postoperative course was uneventful during the 1-year follow-up.ConclusionsThe TEP approach may be feasible for the resection of a CPS and may allow safe and secure resection due to good visibility, even in pediatric patients.

Dataset Information

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

Background

Methods and design

Discussion

Trial registration

Publications

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

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