The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use.

BACKGROUND: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. OBJECTIVE: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. METHODS: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for 'surgical device design in low resource settings' and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. RESULTS: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. CONCLUSIONS: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

Use of intrathecal midazolam or fentanyl as an adjunct to spinal anaesthesia with bupivacaine for lower limb surgery: A randomised controlled study.

BACKGROUND: Intrathecal adjuncts have been used to prolong the quality and duration of subarachnoid anaesthesia. Midazolam given intrathecally is reported to have antinociceptive properties. The purpose of this study was to compare intrathecal midazolam with fentanyl for pain relief and patient comfort. METHODS: In this prospective, double-blind, randomised controlled trial, 90 patients for lower limb surgeries were randomly allocated to three groups: "control group" (3 ml 0.5% heavy bupivacaine), "fentanyl group" (3 ml 0.5% bupivacaine + 10 mcg fentanyl) and "midazolam group" (3 ml 0.5% bupivacaine + 1 mg midazolam). Level, duration, and quality of blocks were compared along with the duration and quality of postoperative analgesia. Haemodynamic stability and any associated complications were also noted. RESULTS: Onset of block was fastest in Group C (28.5 ± 13.48 min) vis-a-vis other groups (35.5 ± 26.05 min for Group "F" and 28.5 ± 23.68 min for Group "M"; P = 0.51). Duration of block was comparable in all groups (130.5 ± 39.3 min Group "C"; 126.5 ± 44.0 min Group "F" and 129.5 ± 45.7 min Group "M"; P > 0.5).Addition of adjuncts did not significantly defer the appearance of pain. Intensity of pain was lower in Group "M". Average VAS scores were lower for Group "M" (3-4) than those for Group "C" (4-5) and Group "F" (4-6).Majority of patients required at least one dose of rescue analgesic; however, those receiving fentanyl reported better quality of postoperative analgesia than those in midazolam group. CONCLUSION: Adjuvants improve quality of postoperative analgesia (fentanyl better than midazolam).

Bimanual, intra-operative, fluoroscopy-guided removal of nasopharyngeal migratory fish bone from carotid space.

AIM: We report a rare and unusual case of a patient with an ingested fishbone which migrated from the oropharynx to the anterior compartment of the retropharyngeal space and then to the deep neck space in the nasopharynx (i.e. the carotid space). This report aims to describe a successful, minimally invasive method of foreign body removal which avoided both major skull base surgery and any potential life-threatening complications. A secondary aim is to highlight the role of intra-operative fluoroscopy, an under-used tool. CASE REPORT: We present a 67-year-old man with a history of fish bone impaction but no fish bone visible on plain X-ray or flexible endoscopy. The diagnosis of fish bone lodged in the retropharyngeal space was confirmed by computed tomography. Surgical exploration of the anterior retropharyngeal space failed to locate the fish bone, as it had migrated to a new, unknown location. Intra-operative fluoroscopy was vital for the removal of the fish bone, as it was impossible to see with the naked eye and had migrated from its previously imaged position. The fish bone was finally retrieved bimanually using external pressure on the submandibular region, which displaced the fish bone, and fluoroscopic guidance, which assisted its removal from the nasopharyngeal lumen. CONCLUSION: To the best of our knowledge, this is the first reported case of bimanual, intra-operative, fluoroscopy-guided, intra-luminal removal of a migratory fish bone from the deep neck space in this region of the nasopharynx.

Incomplete Carney triad--a review of two cases.

A curious association of three rare tumours was described by Carney in 1977. 'Carney's triad' characteristically includes multifocal pulmonary chondroma, gastric stromal sarcoma and extra-adrenal paraganglioma. Patients may exhibit complete or incomplete expression of the triad. Carney acknowledged that, of 79 patients, only 17 possessed all three tumours. We report here two patients with incomplete expression of Carney's triad.

Tolosa-Hunt syndrome: MRI appearances.

A review of MRI findings in seven patients with Tolosa-Hunt syndrome was carried out. Seven patients presented with unilateral painful ophthalmoplegia. Magnetic resonance imaging studies were carried out to evaluate the cavernous sinuses and orbits. Coronal fast spin-echo T2-weighted images and fat-saturated T1-weighted coronal and transverse images with and without contrast enhancement were obtained for the cavernous sinuses and orbits. All patients showed focal-enhancing masses expanding the ipsilateral cavernous sinus. In one patient the mass was extending to the orbital apex and intraorbitally. All patients recovered on corticosteroid therapy and resolution of the masses was documented on follow-up MRI studies in five patients. One patient had a relapse of symptoms after discontinuing therapy. Magnetic resonance imaging studies of the cavernous sinus and orbital apex show high sensitivity for the detection and follow up of inflammatory mass lesions in Tolosa-Hunt syndrome. Magnetic resonance imaging should be the initial screening study in these patients.

Acute bone crises in sickle cell disease: the T1 fat-saturated sequence in differentiation of acute bone infarcts from acute osteomyelitis.

AIM: To prove the hypothesis that acute bone infarcts in sickle cell disease are caused by sequestration of red blood cells (RBCs) in bone marrow, and to evaluate the unenhanced T1 fat-saturated (fs) sequence in the differentiation of acute bone infarction from acute osteomyelitis in patients with sickle-cell disease. MATERIALS AND METHODS: Two studies were undertaken: an experimental study using in-vitro packed red blood cells and normal volunteers, and a retrospective clinical study of 86 magnetic resonance imaging (MRI) studies. For the experimental study containers of packed RBCs were placed between the knees of four healthy volunteers with a saline bag under the containers as an additional control, and were scanned with the pre-contrast T1-fs sequence. Signal intensity (SI) ratios were obtained for packed RBCs:skeletal muscle and packed RBCs:saline. For the clinical study, the SIs of normal bone marrow, packed RBCs, bone and/or soft-tissue lesions, and normal skeletal muscle of 74 patients (86 MRI studies) were measured using unenhanced, T1 fat-saturated MRI. The ratios of the above SIs to normal skeletal muscle were calculated and subjected to statistical analysis. RESULTS: Fifty-one of 86 MRI studies were included in the final analysis. The ratios of SIs for normal bone marrow, packed red cells, bone infarction, acute osteomyelitis, and soft-tissue lesions associated with bone infarct, compared with normal skeletal muscle were (mean+/-SD) 0.9+/-0.2, 2.1+/-0.7, 1.7+/-0.5, 1.0+/-0.3, and 2.2+/-0.7, respectively. The difference in the ratio of SIs of bone infarcts and osteomyelitis was significant (p=0.003). The final diagnoses were bone infarction (n=50), acute osteomyelitis (n=1), and co-existent bone infarction and osteomyelitis (n=2). Seven patients who had suspected osteomyelitis underwent image-guided aspiration. CONCLUSION: Acute bone infarcts in sickle cell disease are caused by sequestration of red blood cells in the bone marrow. The unenhanced, T1-fat-saturated sequence alone is diagnostic for acute bone infarcts. Contrast enhancement aids in the diagnosis of acute osteomyelitis. MRI can thus help in early diagnosis, specific treatment, and preventing empirical antibiotic therapy.

Lithoclast(®) Master in Intracorporeal Lithotripsy during Percutaneous Nephrolithotomy : Our Experience.

BACKGROUND: This study was carried out to compare the efficacy of Lithoclast(®) Master with pneumolithotriptor during percutaneous nephrolithotomy (PNL) in the treatment of renal staghorn calculi. METHODS: In this prospective study, 60 patients suffering from partial or complete staghorn renal stones were included. Patients were divided randomly in two groups : Groups I and II and underwent PNL for removal of stones. In Group I patients, standard pneumolithotriptor and in Group II, Lithoclast(®) Master was used for stone fragmentation. The patients were evaluated for rate of fragmentation/clearance, presence of residual fragments by KUB radiograph/ultrasound. Result was analyzed by Chi-square test. RESULT: The rate of fragmentation using Swiss Lithoclast(®) Master was more effective and quicker in comparison to standard pneumolithotriptor. The average time taken for fragmentation and clearance in Group I using pneumolithotriptor was 65 minutes, whereas it was 58 minutes using Lithoclast® Master, which was statistically significant (p< 0.01). Only 4% patients had significant residual fragments (> 4mm) in Group II and 16 (53%) patients in Group I, which was significant (p < 0.01). The complications in both the modalities were insignificant; one (1.33%) patient had bleeding and three (10%) patients had urine leak in Group I; whereas three(10%) patients had bleeding and five (16.7%) urine leak in Group II. CONCLUSION: Lithoclast(®) Master is an effective intracorporeal lithotripter during percutaneous nephrolithotomy in the treatment of renal staghorn calculi for stone fragmentation/clearance with minimal residual fragments and complications.

Effectiveness of treatment technologies for wastewater pollution generated by Indian pulp mills.

India has a large number of paper manufacturing units, with mills varying in size of operations and type of product, scattered all over the length and breadth of the country. Present study deals with the survey of four different pulp and paper mills (Mill A, Mill B, Mill C and Mill D) in India, differing in their scale of operation as well as raw material usage. Physico-chemical characterization of wastewaters produced by different processing units like digestor house liquors, bleaching section, paper machine backwaters, combined inlet to the ETP and outlet to ETP, for all the four mills, was conducted. Different parameters like pH, Color, COD, BOD, percent Na, SAR, TDS and Total hardness were analyzed and compared. Highly significant differences were thus found between all the processing units of all four mills with p values < 0.01. This evaluation showed that though these mills have effluent treatment facilities installed in their premises, improvements are still needed to increase their efficiencies for treating the discharged wastewaters.

Contrast-enhanced MR angiography (CE-MRA) in the evaluation of vascular complications of renal transplantation.

Vascular complications associated with renal transplantation merit urgent investigation since they are often correctable, and timely intervention can help salvage the graft kidney. Contrast-enhanced MR angiography (CE-MRA) is a promising non-invasive technique, uses relatively non-nephrotoxic contrast agents and can rapidly demonstrate the underlying lesion in most instances. In this pictorial review we present the spectrum of abnormalities, as well as the pitfalls of interpretation of CE-MRA, that we encountered in 41 cases where there was clinical suspicion of vascular complications of renal transplantation. We believe that CE-MRA is a valuable, non-invasive screening technique in these cases, and further investigation and management of these patients can be confidently tailored to the results of the CE-MRA study.

Central nervous system complications in two cases of juvenile onset dermatomyositis.

Central nervous system (CNS) complications are rarely reported in either juvenile or adult onset inflammatory myositides, such as dermatomyositis and polymyositis. We report two children, aged 4 and 10 yr respectively, with a diagnosis of juvenile dermatomyositis, both of whom subsequently developed clinical features of severe CNS involvement, possibly consistent with cerebral vasculopathy. One child died from apparent brainstem involvement; the other developed seizures, pseudoseizures and clinical depression which responded to aggressive immunosuppression. Although the vasculopathy or vasculitis underlying this disorder is known to have a systemic distribution, CNS involvement has rarely been reported and may be under-recognized.

Macrophage activation syndrome: a potentially fatal complication of rheumatic disorders.

AIMS: To review the precipitating events, clinical features, treatment, and outcome of macrophage activation syndrome (MAS). METHODS: Retrospective review of cases of MAS from a prospectively collected database of children with rheumatic diseases from 1980 to 2000. RESULTS: Nine patients (eight girls) were considered to have evidence of MAS. The primary diagnosis was systemic onset juvenile idiopathic arthritis in seven, enthesitis related arthritis in one, and chronic infantile neurological cutaneous articular syndrome in one. Mean age of onset was 5.7 years, and duration prior to MAS, 4.2 years. No medication was identified as a trigger. Eight had infections prior to MAS; specific infectious agents were identified in four. High grade fever, new onset hepatosplenomegaly, and lymphadenopathy were common clinical features. Platelet counts fell dramatically, from an average of 346 to 99 x 10(9)/l. Mean erythrocyte sedimentation rate (in three patients) fell from 115 to 28 mm/h. Eight had abnormal liver function during the disease course, and six had coagulopathy. Bone marrow examination supported the diagnosis with definite haemophagocytosis in four of seven. All received high dose steroids (eight intravenous, one oral), five cyclosporin, two cyclophosphamide, and one antithymocyte globulin. Two of three patients with significant renal impairment died. CONCLUSION: MAS is a rare and potentially fatal complication of childhood rheumatic disorders. Most of our patients were female, and most cases were preceded by infection. Bone marrow studies support the diagnosis. Deranged renal function may be a poor prognostic sign. Aggressive early therapy is essential.

The British version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ).

We report herein the results of the cross-cultural adaptation and validation into the British language of the parent's version of two health related quality of life instruments. The Childhood Health Assessment Questionnaire (CHAQ) is a disease specific health instrument that measures functional ability in daily living activities in children with juvenile idiopathic arthritis (JIA). The Child Health Questionnaire (CHQ) is a generic health instrument designed to capture the physical and psychosocial well-being of children independently from the underlying disease. A total of 440 subjects were enrolled: 219 patients with JIA (17% systemic onset, 41% polyarticular onset, 33% extended oligoarticular subtype, and 9% persistent oligoarticular subtype) and 221 healthy children. The CHAQ clinically discriminated between healthy subjects and JIA patients, with the systemic, polyarticular and extended oligoarticular subtypes having a higher degree of disability, pain, and a lower overall well-being when compared to their healthy peers. Also the CHQ clinically discriminated between healthy subjects and JIA patients, with the systemic onset, polyarticular onset and extended oligoarticular subtypes having a lower physical and psychosocial well-being when compared to their healthy peers. In conclusion the British version of the CHAQ-CHQ is a reliable, and valid tool for the functional, physical and psychosocial assessment of children with JIA.

Polymorphism of bovine major histocompatibility complex (MHC) class I genes revealed by polymerase chain reaction (PCR) and restriction enzyme analysis.

The polymorphic exon 2-exon 3 region of bovine major histocompatibility complex (MHC) class I genes was amplified by polymerase chain reaction (PCR) from genomic DNA samples with characterized class I polymorphism. The primers for amplification were designed in conserved regions at the borders of exons 2 and 3, based on all available cDNA sequences. The primers should, therefore, amplify most expressed class I genes, but may also amplify non-expressed class I genes. The PCR amplified class I gene fragments of 700 bp were characterized on the basis of restriction fragment length polymorphism (RFLP). The PCR-RFLP analysis of class I genes showed that the bands in each digestion could be classified as non-polymorphic, as shared between several bovine lymphocyte antigen (BoLA)-A types, or as specific to a single BoLA-A type. The same primers were then used for amplification of class I gene fragments from eight Sahiwal animals, a breed which originated in the Indian subcontinent. These studies showed that BoLA class I PCR-RFLP could be used to study class I polymorphism in family groups.

MR spectrum in spinal dysraphism.

Spinal dysraphism is a general term which encompasses a wide variety of anomalies of the spine, all of which result from imperfect midline fusion of the embryonic neural tube. This term refers to large defects that involve the spine and not to small vertical clefts commonly seen within the spinal process of L5 or S1. We present a spectrum of MR imaging findings selected from a retrospective review of 100 patients of spinal dysraphism evaluated at our institution.

Alteration of sonographic texture of the endometrium in post-menopausal bleeding. A guide to further management.

BACKGROUND: The purpose of this study was to assess the utility of transvaginal ultrasonography in the evaluation of endometrial morphology in addition to the standard criterion of endometrial thickness for selecting patients for endometrial sampling. METHODS: Two hundred and seven consecutive cases of postmenopausal bleeding were evaluated by transvaginal ultrasound. Endometrial thickness was measured as the maximum anteroposterior thickness of the endometrium including both the anterior and posterior layers, in the sagittal long axis view. The morphology of the endometrium was studied and categorized as homogeneous, focally increased echogenecity, diffusely increased echogenecity or diffusely inhomogeneous. Patients were followed up for clinical course and endometrial histopathology. RESULTS: Textural inhomogeneity was observed in all the three cases of endometrial cancers with endometrial thickness of less than 6 mm, and, in ten out of 11 cases of a more than 6 mm thick endometrium. On the other hand the endometrial texture was homogeneous in all cases of endometrial atrophy/tissue inadequate for diagnosis, with thickness of less than 6 mm. CONCLUSION: This study adds the dimension of abnormal echogenecity of the endometrium to the currently followed criterion of endometrial thickness with a view to enhance accuracy, both for a better prediction of atrophy and a higher prediction for endometrial cancer. Expectant management can be offered to patients with a homogeneous endometrium which is 6 mm thick or less. Aggressive evaluation for a malignancy must be made if there is a focal increased echogenecity or a diffuse increased echogenecity even in a thin endometrium.

Deep-seated thoracic and abdominal masses: usefulness of ultrasound and computed tomography guidance in fine needle aspiration cytology diagnosis.

Fine needle aspiration cytology (FNAC) was performed under ultrasound and CT guidance in 120 cases. These included abdominal masses (85 cases) and thoracic masses (35 cases) biopsied over a two and a half year period (March 1996 to September 1998). The aim of this study was to assess the contribution of clinico-imaging evaluation and image-guided FNAC to the management of patients with deep-seated mass lesions. Aspirations in the abdomen were performed from various anatomic sites such as liver (56 cases), lymph nodes (18 cases), gastrointestinal tract (three cases), pancreas (six cases), and kidney (two cases). In the thorax, biopsy was performed in the lung (19 cases) and mediastinum (13 cases). In 112 cases (93.4%) FNAC was diagnostic. Of the lesions that were successfully aspirated, 85% were < or = 5 cm in size. No major complication was encountered. All the successful aspirates could be defined as malignant or non-malignant, but tissue differentiation was possible in 63.7% of malignant lesions and 53.8% of benign lesions. Combined clinical and imaging evaluation for malignancy showed 80% sensitivity and 59% specificity. Although clinicoradiological parameters themselves have certain limitations in diagnosing benign versus malignant lesions, in conjunction with guided FNA they are very accurate and safe in diagnosing deep-seated mass lesions in the thorax and in the abdomen. However, the role of FNA in tissue differentiation of solid lesions such as lymphoma requires further study.