Equivalence and noninferiority trials – are they viable alternatives for registration of new drugs? (III)

Objectives

Ximelagatran is a novel oral direct thrombin inhibitor. It has favorable pharmacodynamic properties, with a broad therapeutic range without the need for anticoagulation monitoring. We aimed to discover whether ximelagatran offers a genuine future replacement to warfarin for patients in persistent atrial fibrillation (AF).

Materials and methods

We provide an evidence-based review of the relative merits and disadvantages of warfarin and aspirin. We subsequently present an overview of the evidence for the utility of ximelagatran in the treatment of AF.

Results

Adjusted dose warfarin is recommended over aspirin for patients in AF at high risk of future stroke. Some of this benefit is partially offset by the higher bleeding risks associated with warfarin therapy. The SPORTIF III and V studies have shown that ximelagatran is not inferior to warfarin in the prevention of all strokes in patients with AF (both persistent and paroxysmal). This benefit was partially offset by the finding of a significant elevation of liver transaminases (>3 × normal) in 6% of patients.

Conclusions

Current data would suggest that ximelagatran might represent a future alternative to warfarin. The lack of need for anticoagulant monitoring has been partially offset by a need for regular monitoring of liver function. Further data from randomized clinical trials is clearly needed.     

Delayed surgical treatment for a traumatic bilateral cervical facet joint dislocation using a posterior-anterior approach: a case report

Introduction

Advanced abdominal (extrauterine) pregnancy is a rare condition with high maternal and fetal morbidity and mortality. Because the placentation in advanced abdominal pregnancy is presumed to be inadequate, advanced abdominal pregnancy can be complicated by pre-eclampsia, which is another condition with high maternal and perinatal morbidity and mortality. Diagnosis and management of advanced abdominal pregnancy is difficult.

Case presentation

We present the case of a 33-year-old African woman in her first pregnancy who had a full-term advanced abdominal pregnancy and developed gross ascites post-operatively. The patient was successfully managed; both the patient and her baby are apparently doing well.

Conclusion

Because most diagnoses of advanced abdominal pregnancy are missed pre-operatively, even with the use of sonography, the cornerstones of successful management seem to be quick intra-operative recognition, surgical skill, ready access to blood products, meticulous post-operative care and thorough assessment of the newborn.     

Severe upper airway obstruction due to delayed retropharyngeal hematoma formation following blunt cervical trauma

Background

We report a case of severe upper airway obstruction due to a retropharyngeal hematoma that presented nearly one day after a precipitating traumatic injury. Retropharyngeal hematomas are rare, but may cause life-threatening airway compromise.

Case presentation

A 50 year-old man developed severe dyspnea with oropharyngeal airway compression due to retropharyngeal hematoma 20 hours after presenting to the emergency department. The patient also had a fractured first cervical vertebra and was diagnosed with a left brachial plexopathy. The patient underwent emergent awake fiberoptic endotracheal intubation to provide a definitive airway.

Conclusion

Retropharyngeal hematoma with life-threatening airway compromise can develop hours or days after a precipitating injury. Clinicians should be alert to the potential for this delayed airway collapse, and should also be prepared to rapidly secure the airway in this patient population likely to have concomitant cervical spinal or head injuries.     

Paraneoplastic limbic encephalitis presenting as a neurological emergency: a case report

Introduction

Dentin dysplasia is a rare hereditary disturbance of dentin formation characterized by defective dentin development with clinically normal appearing crowns, severe hypermobility of teeth and spontaneous dental abscesses or cysts. Radiographic analysis shows obliteration of all pulp chambers, short, blunted and malformed or absent roots and peri-apical radiolucencies of non carious teeth.

Case presentation

We present a case of dentin dysplasia type I in a 12-year-old Iranian boy, and the clinical, radiographic and histopathologic findings of this condition and treatment are described.

Conclusions

There are still many inconclusive issues in the diagnosis and management of patients with dentin dysplasia. The diagnostic features of this rare disturbance will remain incompletely defined until additional cases have been described. Early diagnosis of the condition and initiation of effective regular dental treatments may help these patients to prevent or delay loss of dentition.     

Non-invasive algorithm for bowel motility estimation using a back-propagation neural network model of bowel sounds

Background

Although cardiac auscultation remains important to detect abnormal sounds and murmurs indicative of cardiac pathology, the application of electronic methods remains seldom used in everyday clinical practice. In this report we provide preliminary data showing how the phonocardiogram can be analyzed using color spectrographic techniques and discuss how such information may be of future value for noninvasive cardiac monitoring.

Methods

We digitally recorded the phonocardiogram using a high-speed USB interface and the program Gold Wave http://www.goldwave.com in 55 infants and adults with cardiac structural disease as well as from normal individuals and individuals with innocent murmurs. Color spectrographic analysis of the signal was performed using Spectrogram (Version 16) as a well as custom MATLAB code.

Results

Our preliminary data is presented as a series of seven cases.

Conclusions

We expect the application of spectrographic techniques to phonocardiography to grow substantially as ongoing research demonstrates its utility in various clinical settings. Our evaluation of a simple, low-cost phonocardiographic recording and analysis system to assist in determining the characteristic features of heart murmurs shows promise in helping distinguish innocent systolic murmurs from pathological murmurs in children and is expected to useful in other clinical settings as well.     

Predicting invasion in mammographically detected microcalcifcation: a preliminary report

Background

Malignant pleural mesothelioma is a rare malignancy. The outcome remains poor despite complete surgical resection.

Patients and methods

Eleven patients with histologicaly proven epithelial type malignant pleural mesothelioma undergoing extrapleural pneumonectomy with systemic chemotherapy and/or radiotherapy before and after surgical resection were retrospectively reviewed.

Results

Ten out of 11 patients underwent complete surgical resection, of these 7 patients had stage I disease. Of these 7 patients, 5 are alive without any recurrence, a 2-year survival rate of 80% was observed in this group. There was no operative mortality or morbidity.

Conclusion

Extrapleural pneumonectomy with perioperative adjuvant treatment is safe and effective procedure for epithelial type malignant pleural mesothelioma.     

Traumatismes fermés des bourses: stratégie de prise en charge

Introduction

Blunt scrotal trauma is increasingly frequent, but surgical exploration of these cases of trauma remains controversial. The objectives of this study were to assess the diagnostic value of clinical examination and ultrasound in testicular trauma and to analyse the complications of the various treatments proposed (surgical and medical treatments), in order to more clearly define the place of medical or surgical treatment in this form of trauma in young adults.

Patients and Methods

130 cases of blunt scrotal trauma were managed between 1993 and 2004. In the absence of clinical and ultrasound criteria of severity (haematocele, very large intratesticular haematoma, rupture of the tunica albuginea), medical treatment consisting of rest, anti-inflammatory drugs, and testicular support was instituted. Surgical exploration was performed when serious lesions of the testis were suspected. Scrotal ultrasound was performed in 68 patients and 46 of them underwent scrotal exploration. The sensitivity and specificity of scrotal ultrasound were determined by comparing radiological findings with definitive intraoperative findings. The immediate morbidity and long-term sequelae were analysed.

Results

The mean age of the patients was 24 years (range: 4 to 73 years). The clinical features were dominated by pain (73.8%) and scrotal swelling (89.2%). The sensitivity of testicular ultrasound was 34.7% for testicular rupture, 100% for testicular contusions, 33.3% for intratesticular hematoma and 76.9% for haematocele. Medical and surgical treatments were instituted in 29.2% and 70.7% of cases, respectively. With a mean follow-up of 8 months, chronic pain and testicular atrophy were observed in 18% and 5.5% of cases, respectively.

Conclusion

In the absence of signs of severity, medical treatment with regular surveillance remains justified. However, in the presence of doubtful clinical or ultrasound findings, surgical exploration must be performed as soon as possible     

Traumatisme du testicule chez l’enfant

Introduction

The testicular trauma is uncommon in children and the literature about this topic is very poor. The aim was to investigate the testicular trauma in children from a retrospective study.

Materials and methods

All the French pediatric surgical departments were requested to send their cases of testicular trauma reported between 2000 and 2009. The analysis was performed from the data and the operative report. Isolated scrotal wounds, testicular torsions revealed by trauma, and incomplete files were excluded.

Results

Fifteen departments sent their data and 2 had no cases. From 60 cases, 15 were excluded and 45 selected. The mean age was 12.3 years (2 days–18 years). The circumstances of the trauma were 23 knocks (foot, knee, and fist), 13 falls, 4 motorcycle accidents, 4 unknown traumas, and 1 obstetrical trauma. There were 4 wounds and 41 without wound. A color Doppler sonography was performed in 34 cases (75.5%) with an accurate diagnosis in 30 cases; 2 testicular fractures and 1 intratesticular hematoma were not confirmed at surgery, and 1 epididymal hematoma was not seen on sonography. The lesions were testicular fractures (15), intratesticular hematomas (8), benign testicular blunt traumas (6), spermatic cord hematomas (6), epididymal hematomas (6), isolated hematoceles (3), and avulsion (1). Surgical treatment was done in 33 children and 12 had nonoperative treatment. Among the 15 testicular fractures, 13 were operated (8 sutures and 5 partial orchidectomies) and 2 were only observed. For the intratesticular hematomas, a surgical treatment was performed in 5 children and a nonoperative treatment in 3, with a good evolution. Only 20 children were controlled beyond 4 months, especially the testicular fractures and no secondary testicular atrophy was seen.

Conclusion

The testicular trauma in children is rare and the prognosis is rather good. The color Doppler sonography now allows a good diagnosis in most cases and the surgery can be often avoided in benign blunt trauma. In this situation, it is important to repeat sonography 24 or 48 hours after trauma to ensure there is no fracture or other lesion necessitating a surgical treatment.     

Effect of left atrial compliance on pulmonary artery pressure: a case report

Background

Pericardial tumours are unusual and may be difficult to characterise with imaging. They manifest as large, non-contractile, solid masses within the pericardium. Presenting symptoms include heart failure, arrythmias, sudden death, cyanosis and chest pain.

Case presentation

We describe a case of massive pericardial fibroma in a 52 year old woman, who presented with palpitations only.

Conclusion

We illustrate the different imaging modalities available to image this tumour prior to surgical resection, and indicate the strengths and weaknesses of each.     

Les fistules péniennes urétrocutanées postcirconcision: à propos de 85 cas

Purpose

To assess clinical and therapeutic aspects of penile urethral fistula following circumcision in our daily urological practice.

Patients and methods

We carried out a retrospective study of cases of penile fistula between 1990 and 2007.

Results

A series of 85 cases is reported. The mean age was 10.7 years (15 months-38 months). The circumcision was performed by paramedical persons in the majority of cases. The mean period elapsing before consultation was 4.1 ± 5.3 years (range: 1 week-28 years). The fistula was associated with partial amputation of the glans penis in one case, and with urethral meatus stenosis in three cases. The surgical treatment was layered repair in the majority of cases. The average follow-up was 3.35 years (range: 2 months-8 years). Overall results were satisfactory in 81.2% of cases.

Conclusions

Penile fistula due to circumcision is common in our region. Its management is codified but there is a significant risk of failure, making prevention even more important.     

Extragonadal germ cell tumor presenting in a woman with systemic lupus erythematosus: a case report

Introduction

Esophageal intramural pseudodiverticulosis is a rare condition characterized by the dilatation of the submucosal glands.

Case presentation

We present a case of esophageal intramural pseudodiverticulosis in a 72-year-old Caucasian man who presented with dysphagia and with a background history of alcohol abuse. An upper gastrointestinal endoscopy of our patient showed an esophageal stricture with abnormal mucosal appearances, but no malignant cells were seen at biopsy. Appearances on a barium esophagram were pathognomonic for esophageal intramural pseudodiverticulosis.

Conclusion

We demonstrate the enduring usefulness of barium esophagography in the characterization of abnormal mucosal appearances at endoscopy.     

"Pseudosarcoma" in a pregnant woman

Background

As a result of improvements in diagnostic accuracy, the primary source of the tumour is identified in more than 99% of cases presenting with a malignancy. Whilst the axial skeleton is a common site of metastases, the sternum is rarely affected, especially by isolated metastases.

Case presentation

We report a case of a 68 year old male who was referred to the surgical outpatient clinic with a six month history of sternal pain. The patient was known to have essential thrombocythaemia, which had recently transformed into acute myeloid leukaemia but a sternal biospy showed mucinous adenocarcinoma. He had not localising symptoms and full evaluation failed to localise the primary tumour.

Conclusion

Solitary sternal metastases are rare and when found an underlying neoplasm is usually identified allowing targeted treatment. If however, there is no symptomatic tumour, the metastasis should simply be treated symptomatically.     

Morphological and growth altering effects of Cisplatin in C. albicans using fluorescence microscopy

Background

Extrapulmonary manifestations of tuberculosis have become increasingly important in the era of HIV/AIDS.

Case presentation

We describe a case of tuberculosis (TB) dactylitis in a patient with AIDS who originated from the Ivory Coast. The diagnosis was established by direct visualization of acid-fast bacilli on joint fluid and bone biopsy of the proximal phalanx. Imaging of the chest revealed multiple bilateral nodules. Confirmation of the diagnosis was made by isolation of Mycobacterium tuberculosis from sputum and bone cultures.

Conclusion

Tuberculosis should be considered in patients with unusual soft tissue or skeletal lesions, especially when an immunosuppressive condition is present. Ziehl-Neelsen staining and culture of tissue obtained via surgical biopsy offer the most direct approach to diagnosis.     

Un câblage inhabituel dans l’urètre

Objective

To describe an unusual case of a urethral foreign body.

Methods and results

This was a case of an intraurethral foreign body in a man aged 32 with previous psychiatric problems, who had inserted an electric cable into his urethra. This was managed by surgical removal via a perineal approach.

Conclusion

The treatment of intraurethral foreign bodies is usually endoscopic, but in some cases open surgery is necessary.     

Cancer du pénis au Sénégal : aspects cliniques et thérapeutiques

Objective

Describe the clinical and therapeutic aspects of penile cancer in Senegal.

Patients and methods

We conducted a retrospective study that looked at records of patients followed for penile cancer in the urology service of the Aristide Le Dantec hospital between January 2000 and December 2011.

Results

Eight patients of mean age of 51.5, with extremes of 27 and 77 have been identified. They were all circumcised in childhood. Clinical examination had highlighted ulcerated and burgeoning tumor affecting glans and a part of the penis in five cases; in two cases, it concerned the entire penis, while one case was limited to the glans. Patients were thus classified according cT3 (three cases) and cT1 (one case). The histological type of the tumour was, in all patients, squamous cell carcinoma. There was no secondary location in the thoracic-flow-pelvic scanner. Therapeutically, a partial penectomy was conducted in five cases, a total penectomy with ganglionic flushing in one case. Two patients refused surgical treatment. There was no recurrence in five patients who underwent a partial amputation of the penis. Overall survival was therefore of 83.3 for surgical patients.

Conclusion

cancer of the penis is rare in Senegal. The support is delicate because of late diagnosis associated with advanced lesions, hence the importance of awareness of the population.     

Relapsing polychondritis associated with bilateral stapes footplate fixation: a case report

Introduction

Two types of gliomatosis cerebri exist: Type I and Type II. We report the results of a histological and genetic study of two cases of gliomatosis cerebri Type II, correlating these results with therapy and prognosis.

Case presentation

Two patients, a 52-year-old man (Patient 1) and a 76-year-old man (Patient 2) with gliomatosis cerebri II were admitted to our institution; they underwent surgical treatment and received radiotherapy and chemotherapy. At the 24-month follow-up, Patient 1 was still alive, while Patient 2 had died. The poor prognosis of Patient 2 was underlined by molecular analysis which showed that the angiogenesis related genes VCAM1 and VEGF were overexpressed, reflecting the high degree of neovascularization.

Conclusion

Genes involved in drug resistance and metallothioneins were highly expressed in Patient 2 and this, associated with unmethylated O6-methylguanine methyltransferase, can explain the lack of response to chemotherapy.     

Neonatal tooth with Riga-Fide disease affecting breastfeeding: a case report

Background

Neonatal teeth erupt during the neonatal period and natal teeth are the presence of teeth since birth. While rare, natal teeth and neonatal teeth can have a significant impact on breastfeeding. Neonatal teeth are less common, and although its exact etiology is still unknown, it can cause difficulties in breastfeeding to the mother and may eventually lead to discontinuation of breastfeeding. Other associated possible complications include tooth aspiration and sublingual ulceration. This paper was aimed to discuss the clinical features, complications, and management of neonatal tooth, in addition to its impact on breastfeeding and role in sublingual ulcer formation.

Case presentation

We present a baby girl who had a neonatal tooth with sublingual ulceration (Riga-Fede disease), which resulted in a difficulty to breastfeed for the baby and nipple pain to the mother. Following the extraction of the baby’s tooth, she immediately continued breastfeeding, and her tongue ulcer healed well.

Conclusion

Extraction of the neonatal tooth promoted rapid healing of oral ulcers and the reestablishment of breastfeeding.

     

La fracture de verge à Dakar. à propos de 25 cas

Objectives

To describe the epidemiological, clinical and therapeutic characteristics of penile fracture in the department of Urology-Andrology of h?pital général de Grand Yoff, Dakar, Sénégal.

Materials and methods

We reviewed the medical records of cases of penile fracture managed at the h?pital général de Grand Yoff from January 2001 to December 2011. The data of interest were: age at diagnosis, geographic origin, clinical presentation, surgical findings, treatment and outcomes.

Results

In ten years, 25 cases of penile fracture were found with an average of 2,5 cases per year and patients mean age of 36 years with 22 and 60 years as extremes. The circumstances of occurrence were mainly forced manipulation (52%) and coitus (32%). Pain associated with penile curvature, swelling localized to the penis or extending to the pubis or the perineum were the major clinical findings. A prompt emergency (mean time for providing care was 2 hours ranging from 45 minuts to 2 days) surgical explorationwith suture of the albuginea of the corpus cavernosum was the treatment in all cases.

Conclusion

Penile fracture is a relatively uncommon urological emergency in our setting. The diagnosis is easy, mostly based on clinical examination. A prompt and appropriate surgical management is the key to cosmetic and functional outcomes.     

Maladie de La Peyronie: Bilan IRM chez 28 patients

Purpose

to determine diagnosis and prognosis value of MRI in Peyronie’s disease.

Material and Methods

thirty one penile MR examinations have been performed in 28 patients aged between 21 and 73. (1 tesla; surface coil; sagittal SET1, axial SET2 weighted, T1 before and after Gadolinium)

- In all cases but one, fibrous plaques were clinically palpable.

- Images were compared with clinical examination and evolution under anti-inflammatory drugs.

Results

- In 3 cases, MRI misdiagnosed one unique plague.

- In 2 additional cases, one of the 2 clinical plaques was not detected.

- In 5 cases, MRI depicted more lesions than palpation.

- Gadolinium Enhancement was always correlated with a good response to anti-inflamatory drugs but this treatment was also useful in one case who showed no enhancement.

Conclusion

MRI can be helpfull in the pretreatment assessment and int he follow-up of Peyronie’s disease.