Adjuvant statin therapy for oesophageal adenocarcinoma: the STAT-ROC feasibility study.

BACKGROUND: Statins inhibit proliferative signalling in oesophageal adenocarcinoma (OAC) and their use is associated with better survival in observational studies. The present study was undertaken to examine the feasibility of assessing adjuvant statin therapy in patients with operable OAC in a phase III RCT. METHODS: For this multicentre, double-blind, parallel-group, randomized, placebo-controlled feasibility trial, adults with OAC (including Siewert I-II lesions) who had undergone oesophagectomy were centrally allocated (1 : 1) to simvastatin 40 mg or matching placebo by block randomization, stratified by centre. Participants, clinicians and investigators were blinded to treatment allocation. Patients received treatment for up to 1 year. Feasibility outcomes were recruitment, retention, drug absorption, adherence, safety, quality of life, generalizability and survival. RESULTS: A total of 120 patients were assessed for eligibility at four centres, of whom 32 (26·7 per cent) were randomized, 16 in each group. Seven patients withdrew. Participants allocated to simvastatin had lower low-density lipoprotein cholesterol levels by 3 months (adjusted mean difference -0·83 (95 per cent c.i. -1·4 to -0·22) mmol/l; P = 0·009). Median adherence to medication was greater than 90 per cent between 3 and 12 months' follow-up. Adverse events were similar between the groups. Quality-of-life data were complete for 98·3 per cent of questionnaire items. Cardiovascular disease, diabetes and aspirin use were more prevalent in the non-randomized group, whereas tumour site, stage and grade were similar between groups. Survival estimates were imprecise. CONCLUSION: This RCT supports the conduct and informs the design considerations for a future phase III trial of adjuvant statin therapy in patients with OAC. Registration number: ISRCTN98060456 (www.isrctn/com).

ANTECEDENTES: Las estatinas inhiben las señalizaciones proliferativas en el adenocarcinoma de esófago (oesophageal adenocarcinoma, OAC) y su uso se asocia con mejor supervivencia en estudios observacionales. El presente estudio se llevó a cabo para examinar la viabilidad de evaluar el tratamiento adyuvante con estatinas en pacientes con OAC operable en un ensayo aleatorizado y controlado de fase III. MÉTODOS: En este ensayo de viabilidad controlado por placebo, aleatorizado, de grupos paralelos, doble ciego y multicéntrico, los pacientes adultos con OAC (incluyendo lesiones Siewert I/II) que fueron sometidos a esofaguectomía se asignaron de forma centralizada (1:1) a tratamiento con simvastatina 40 mg o placebo equivalente mediante aleatorización en bloques, estratificados por centro. Los participantes, los clínicos y los investigadores desconocían la asignación del tratamiento. Los pacientes recibieron el tratamiento hasta un año. Los resultados de viabilidad fueron reclutamiento, retención, absorción del fármaco, adherencia, seguridad, calidad de vida, generalización, y supervivencia. RESULTADOS: Un total de 120 pacientes fueron evaluados para elegibilidad en 4 centros, de los cuales 32 (26,7%) fueron aleatorizados, 16 en cada grupo. Siete pacientes abandonaron el ensayo. Los pacientes asignados a tratamiento con simvastatina tenían niveles de colesterol LDL más bajos a los 3 meses (diferencia media ajustada, −0,83 mmol/L, i.c. del 95% −1,4 a −0,22, P = 0,009). La mediana de la adherencia a la medicación fue mayor del 90% entre los 3-12 meses de seguimiento. Los eventos adversos fueron similares entre los grupos. Los datos de calidad de vida estaban completos en el 98,3% de las preguntas del cuestionario. Enfermedad cardiovascular, diabetes y uso de aspirina eran más prevalentes en el grupo no aleatorizado, mientras que la localización del tumor, el estadio y el grado fueron similares entre los grupos. Las estimaciones de supervivencia fueron imprecisas. CONCLUSIÓN: Este RCT apoya la realización e informa de las consideraciones de diseño para un futuro ensayo de fase III de tratamiento adyuvante con estatinas en pacientes con OAC.

Penetrating foreign body in the masticator space with injury to the internal maxillary artery: a surgical challenge.

INTRODUCTION Foreign bodies (FBs) in the masticator space (MS) are a unique problem because of the difficulty of accessing this deep compartment within the head and neck. In addition, MS contents include critical structures such as the internal maxillary artery (IMA) and mandibular nerve. CASE HISTORY A 39-year-old tradesman was involved in a construction accident whereby a metallic projectile from a machinery drill penetrated his left cheek. Computed tomography revealed a metallic object of dimension 1.9 ×1.2 cm within the MS, with concomitant fracture of left maxillary anterior and lateral walls. Surgery was indicated in view of constant pain and swelling. The FB was removed through the cheek laceration with the aid of an X-ray image intensifier. Persistent significant bleeding was observed within the wound cavity after FB removal that could not be arrested despite attempts at haemostasis with adrenaline packing and oxidised cellulose polymers. Urgent selective left external carotid angiography showed breach of a distal branch of the left internal maxillary artery with contrast extravasation. Embolisation of this branch was undertaken successfully with a liquid agent. CONCLUSIONS This is the first time a FB within the MS with injury to the internal maxillary artery has been described.

A prospective, randomized, single-blind trial of 5-mm versus 3-mm ports for laparoscopic cholecystectomy: is smaller better?

BACKGROUND: Single-incision laparoscopic cholecystectomy (SILC) is said to provide improved cosmesis with a reduction in postoperative pain, but SILC involves a change in operative technique. A single-blind, randomized controlled trial compared cosmetic outcomes and postoperative pain between 3- and 5-mm ports used for laparoscopic cholecystectomy (LC). METHODS: For this study, 80 patients with symptomatic gallstones were recruited from a single center and randomized to a LC using either a 5-mm port and three 3-mm ports (group A) or a 10-mm port and three 5-mm ports (group B). Operative details; pain scores at 1 h, 6 h, and 1 week; and analgesia required during the first week were collected. Cosmetic outcome was assessed at 6 months using a validated questionnaire. RESULTS: For each group, 40 patients were recruited. The two groups were well matched except for sex. Group A had 11 males, and Group B had 4 males. The mean operative time was 49 ± 12 min (range, 24-120 min) in the 3-mm group versus 46 ± 19 min (range, 21-124 min) in the control group (p = 0.40). The two groups did not differ statistically in the day case rate. The pain scores in Group A were 2.5 ± 2.1 at 1 h, 3.2 ± 2.2 at 6 h, and 0.8 ± 2.2 at 1 week versus 4.2 ± 2.9 at 1 h, 3.3 ± 2.4 at 6 h, and 2.1 ± 2.4 at 1 week in Group B (p = 0.003, 0.63, and 0.002, respectively). No difference in the analgesia consumption was observed during the first postoperative week. The patients in Group A had significantly better cosmetic outcome scores at 6 months. CONCLUSION: The use of 3-mm ports is technically feasible in patients undergoing LC for gallstones. The operating times are comparable with those for conventional LC, whereas the pain scores are reduced, and the cosmetic outcome is better.

Proliferating tricholemmal tumour: clinicopathological aspects of a case.

We report the case of a 49-year-old man who presented with an enlarging mass over his occipital scalp. The clinical impression was either a squamous cell carcinoma or an unusual adnexal tumour. A wide excision was performed with skin grafting. Gross examination revealed a large exophytic tumour mass measuring 10 cm. Histopathological examination showed a circumscribed, well-differentiated squamoproliferative lesion with a lobulated architecture. Clear cell features, pilar-type keratinisation, microcalcifications and the presence of mucinous degeneration were noted. A diagnosis of proliferating tricholemmal tumour was made. This entity incorporates a spectrum of lesions, ranging from the mostly benign proliferating tricholemmal cyst to tumours having more atypical cellular and invasive features, the latter features correlating with an increased capacity for aggressive behaviour. Management-wise, such tumours require complete excision with follow-up. As the tumours are often large in size at presentation, reconstruction is required.

Creation of an intermammary sulcus in congenital synmastia.

Synmastia is a condition where both breasts appear conjoint without an intervening intermammary sulcus. This is usually the result of technical complications during breast implant surgery caused by over-dissection of the medial pocket over the sternum in the subglandular plane, or by an over-division of the pectoralis muscle origin along the sternum in a submuscular plane. As a congenital problem, this is very rare with only a single previous report of an attempt to correct this anomaly. We report a rare case of synmastia in a 19-year-old Indian woman. She had no previous surgery or family history of the condition. Vertical-scar reduction mammoplasty was performed for the hypertrophic breasts. Using the same access, the synmastia was corrected. This approach avoided incisions on the sternum, which is one of the keloid-prone sites on the body. Eight months postoperation, the intermammary sulcus was maintained.

Cerclage-wiring-assisted fixation of difficult hand fractures.

Difficult hand fractures with multiple butterfly fragments, multiple cortical splits or intraarticular extension continue to pose a challenge for optimal stable fixation that allows early postoperative mobilisation. In this study, we describe the use of cerclage-wire-assisted fixation of 17 difficult hand fractures in 16 patients. The cerclage wires helped to maintain the reduction, so providing sufficient initial stability for placement of a plate and screws. Stable fixation of the fracture was then accomplished without losing the reduction. One to three cerclages of stainless-steel wires were used for the preliminary fixation. Stable fixation was then accomplished by a bridging or neutralising plate technique. Postoperatively, the fixation was sufficiently stable to allow immediate mobilisation. With an average follow up of 44.5 months, all 17 fractures united without loss of reduction. At final follow-up, the average total active range of motion was 247 degrees (range 220-260 degrees ).

Massive ascites--an uncommon presentation of endometriosis.

Endometriosis as a cause of massive ascites is very rare. It is seldom possible to arrive at the diagnosis without surgical exploration. We describe a case of this entity which presented to us as a surgical problem. This proved to be a diagnostic dilemma to us and our colleagues in other disciplines, with the diagnosis being made based on histology after surgical exploration. The literature is reviewed and we hope our experience in this case will increase the awareness of this uncommon entity.

Microchip injection and separation anomalies due to pressure effects.

While performing routine electroosmotically driven CE separations on microfluidic chips, we have observed peak shape, migration time, and baseline drift anomalies. Pressure-driven backflow (opposing electroosmotic flow (EOF)) has been observed and characterized, and meniscus surface tension (Laplace pressure) is cited as the likely cause. However, there are a number of interdependent factors that affect bulk flow in a microchip environment, including evaporation, buffer depletion due to hydrolysis, EOF pumping, siphoning, viscosity changes due to Joule heating, and Laplace pressure. Given the complexity of such a system, pressure effects were isolated from EOF, and to some extent, siphoning effects were isolated from suspected meniscus effects. Pressure flow observed in the absence of an applied field ranged from 0.4 to 0.8 mm/s, which was on the order of the EOF generated experimentally, 0.6 mm/s at a field of 150 V/cm, and was some 10-20 times larger than what would be predicted merely from a difference in liquid levels (siphoning). Furthermore, experiments were performed without an electric field and with the chip tilted so that meniscus flow ran "uphill" against a siphoning backflow and showed siphoning flow to have a negligible effect upon meniscus flow under the microchip conditions studied. These findings are relevant to the profusion of microfluidic and array-based technology that also use microliter liquid volumes in like-sized reservoirs with similar menisci.