Higher Recurrence Rate After Endoscopic Totally Extraperitoneal (TEP) Inguinal Hernia Repair With Ultrapro Lightweight Mesh: 5-Year Results of a Randomized Controlled Trial (TULP-trial).

OBJECTIVE: The aim of this study was to determine inguinal hernia recurrence rates 5 years after endoscopic totally extraperitoneal (TEP) inguinal hernia repair when either lightweight or heavyweight mesh was used. BACKGROUND: Recurrence is an important complication of inguinal hernia surgery. Higher recurrence rates of Ultrapro lightweight meshes after TEP repair have been demonstrated, yet data regarding long-term follow-up are limited. METHODS: From 2010 to 2012, 950 male adult patients with primary unilateral hernias were randomized to TEP hernia repair with heavyweight (Prolene) or lightweight (Ultrapro) mesh. Five years postoperatively, the validated PINQ-PHONE telephone questionnaire was carried out. Participants with a positive questionnaire reply were scheduled for a clinical visit. A recurrence was defined as a clinically detectable bulge in the operated groin on physical examination. RESULTS: Data on development of recurrence could be obtained from 790 patients (83.2% 5-year follow-up rate). Four patients presented with a recurrence at the outpatient clinic between 2 and 5 years postoperatively. Thirty-five patients (4.6%) with a positive PINQ-PHONE reply (60.0% lightweight vs 40.0% heavyweight) were physically examined at the outpatient clinic. In 2 patients (lightweight) a recurrence was detected. The total 5-year recurrence rate after TEP hernia repair was 2.4% (3.8% lightweight, 1.1% heavyweight, P = 0.01). A significantly higher recurrence rate for lightweight mesh in primary direct hernias was found (P = 0.003). CONCLUSIONS: The overall recurrence rate 5 years after TEP repair was low. Ultrapro lightweight meshes showed higher recurrence rates than heavyweight meshes and are not recommended for endoscopic TEP inguinal hernia repair.

Long-term Results of a Randomized Double-blinded Prospective Trial of a Lightweight (Ultrapro) Versus a Heavyweight Mesh (Prolene) in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair (TULP-trial).

OBJECTIVE: The aim of the randomized clinical trial was to compare the 2 years of clinical outcomes of a lightweight (Ultrapro) vs a heavyweight (Prolene) mesh for laparoscopic total extraperitoneal (TEP) inguinal hernia repair. BACKGROUND: Lightweight meshes reduce postoperative pain and stiffness in open anterior inguinal hernia repair. The discussion about a similar benefit for laparoscopic repair is ongoing, but concerns exist about higher recurrence rates. METHODS: Between March 2010 and October 2012, male patients who presented with a primary, reducible unilateral inguinal hernia who underwent day-case TEP repair were eligible. Outcome parameters included chronic pain, recurrence, foreign body feeling, and quality of life scores. RESULTS: During the study period, 950 patients were included. One year postoperatively the presence of relevant pain (Numeric Rating Score 4-10) was significantly higher in the lightweight mesh group (2.9%) compared with the heavyweight mesh group (0.7%) (P = 0.01), and after 2 years this difference remained significant (P = 0.03). There were 4 (0.8%) recurrent hernias in the heavyweight mesh group and 13 (2.7%) in the lightweight group (P = 0.03). No differences in foreign body feeling or quality of life scores were detected. CONCLUSIONS: In TEP hernia surgery, there was no benefit of lightweight over heavyweight meshes observed 2 years postoperatively.

The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP) hernia repair (TULP): study protocol for a randomized controlled trial.

BACKGROUND: The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias (short: TULP trial). METHODS AND DESIGN: The TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro) and heavyweight (Prolene) mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age) with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4-10). Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL), recurrence rate, patient satisfaction and complications. DISCUSSION: Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP) hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed. TRIAL REGISTRATION: The TULP study is registered in the Dutch Trial Register (NTR2131).

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

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).

Mechanism, assessment, and incidence of male infertility after inguinal hernia surgery: a review of the preclinical and clinical literature.

BACKGROUND: The treatment of inguinal hernia has changed considerably over the past 15 years. We reviewed the preclinical and clinical literature to find out the effect of inguinal hernia surgery on male fertility because it has been suggested that hernia surgery may impair testicular function and male fertility. DATA SOURCES: A search on Embase, MEDLINE, and the Cochrane Library was performed to find related articles. CONCLUSIONS: Animal models show substantial effects of hernia repair on the structures in the spermatic cord, which is more pronounced in mesh repairs. Although the number of studies and the included numbers of patients were limited, clinical studies indicate that these potential adverse effects do not seem to have a clinical impact on male fertility in humans with inguinal hernias. Future clinical studies, preferably with bilateral patients, are necessary to investigate the clinical relevance of the effects of inguinal hernia and hernia surgery on male fertility.

Temporary end ileostomy with subcutaneously buried efferent limb: results and potential advantages.

PURPOSE: To evaluate the results of a modified technique of creating a defunctioning end ileostomy. METHODS: Medical records of all consecutive patients with a defunctioning end ileostomy with buried efferent limb operated at our hospital between January 2000 and December 2007 were reviewed. The defunctioning end ileostomy with buried efferent limb is created by closing the distal limb and positioning it in the subcutis. Parameters studied were: stomal and reversal related complications. RESULTS: 66 patients were included. Between construction and closure of the stoma, a total of 21 patients (31.8%) developed stoma-related complications. In 1 patient (1.5%) high output occurred, in 6 (9%) stomal retraction and in 4 (6.1%) a parastomal hernia occurred. Peristomal skin problems were observed in 14 patients (21.2%) in the early postoperative period, decreasing to 6 patients (9.1%) after 3 weeks. In 1 patient, stoma closure could not be performed through a local approach and formal laparotomy was necessary. Complications of loop ileostomy as reported in the literature show relatively high rates of peristomal skin and leakage problems. CONCLUSIONS: Our results suggest that end ileostomy with subcutaneous buried efferent limb offers advantages over loop ileostomy with regard to the risk of developing peristomal skin and leakage problems.