Dataset Information

Bilateral and Unilateral Total Extraperitoneal Inguinal Hernia Repair (TEP) have Equivalent Early Outcomes: Analysis of 9395 Cases.

ABSTRACT:

Introduction

To date, no randomized controlled trials have been carried out to compare the perioperative outcome of unilateral and bilateral inguinal hernia repair using an endoscopic technique. In a Swiss registry study comparing unilateral with bilateral inguinal hernias, no further details were given regarding the nature of the intra- and postoperative complications. In addition, some authors have raised the issue of prophylactic repair of a clinically healthy other groin side.

Patients and methods

In the Herniamed Registry, in total 9395 patients with a TEP were enrolled. These comprised 6700 patients with unilateral (71.31%) and 2695 patients (28.69%) with bilateral inguinal hernia repair. The outcome variables, analyzed in a multivariable model, were the intra- and postoperative as well as general complication rates, reoperation rate, duration of operation, and length of hospital stay.

Results

While no significant difference was found in the overall number of intraoperative complications between the unilateral and bilateral group (p=0.310), a significantly higher number of urinary bladder injuries in the bilateral TEP operation of 0.28% compared with 0.04% for unilateral TEP (p=0,008) were noted. The greater probability of reoperation (0.82% for unilateral vs. 1.78% for bilateral TEP; p<0,001) in the unadjusted analysis was confirmed in the multivariable model [OR 2.35 (1.504; 3.322); p=0.001]. A significantly higher intraoperative urinary bladder injury rate and reoperation rate because of postoperative surgical complications constitute a difference in the perioperative outcome between unilateral and bilateral TEP which that warrants attention. Based on these results, prophylactic operation of the healthy other groin should not be recommended.

SUBMITTER: Kockerling F

PROVIDER: S-EPMC4496500 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Bilateral and Unilateral Total Extraperitoneal Inguinal Hernia Repair (TEP) have Equivalent Early Outcomes: Analysis of 9395 Cases.

Köckerling F F Schug-Pass C C Adolf D D Keller T T Kuthe A A

World journal of surgery 20150801 8

<h4>Introduction</h4>To date, no randomized controlled trials have been carried out to compare the perioperative outcome of unilateral and bilateral inguinal hernia repair using an endoscopic technique. In a Swiss registry study comparing unilateral with bilateral inguinal hernias, no further details were given regarding the nature of the intra- and postoperative complications. In addition, some authors have raised the issue of prophylactic repair of a clinically healthy other groin side.<h4>Pat ...[more]

PMID: 25832474

Similar Datasets

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:BackgroundTo 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 designThe 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.DiscussionThe 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 registrationThe MAIN study is registered in the Dutch Trial Register (NTR2208).

Dataset Information

Bilateral and Unilateral Total Extraperitoneal Inguinal Hernia Repair (TEP) have Equivalent Early Outcomes: Analysis of 9395 Cases.

Introduction

Patients and methods

Results

Publications

Bilateral and Unilateral Total Extraperitoneal Inguinal Hernia Repair (TEP) have Equivalent Early Outcomes: Analysis of 9395 Cases.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets