Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms.

INTRODUCTION: Completion of hand-written consent forms for surgical procedures may suffer from missing or inaccurate information, poor legibility and high variability. We audited the completion of hand-written consent forms and trialled a web-based application to generate modifiable, procedure-specific consent forms. METHODS: The investigation comprised two phases at separate UK hospitals. In phase one, the completion of individual responses in hand-written consent forms for a variety of procedures were prospectively audited. Responses were categorised into three domains (patient details, procedure details and patient sign-off) that were considered "failed" if a contained element was not correct and legible. Phase two was confined to a breast surgical unit where hand-written consent forms were assessed as for phase one and interrogated for missing complications by two independent experts. An electronic consent platform was introduced and electronically-produced consent forms assessed. RESULTS: In phase one, 99 hand-written consent forms were assessed and the domain failure rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparoscopic cholecystectomy was the most common procedure (7/99) but there was significant variability in the documentation of complications: 12 in total, a median of 6 and a range of 2-9. In phase two, 44% (27/61) of hand-written forms were missing essential complications. There were no domain failures amongst 29 electronically-produced consent forms and no variability in the documentation of potential complications. CONCLUSION: Completion of hand-written consent forms suffers from wide variation and is frequently suboptimal. Electronically-produced, procedure-specific consent forms can improve the quality and consistency of consent documentation.

One Step Nucleic Acid Amplification (OSNA) positive micrometastases and additional histopathological NSLN metastases: Results from a single institution over 53 months.

INTRODUCTION: The role of sentinel lymph node micrometastases on histopathological analysis is controversial in axillary staging and management in clinically node negative breast cancer. Long-term studies addressing the clinical relevance of occult breast cancer in sentinel lymph nodes based on molecular analysis are lacking. One Step Nucleic Acid Amplification (OSNA), a highly sensitive assay of cytokeratin 19 mRNA, is used intra-operatively for the detection of lymph node macro- and micrometastases in breast cancer. AIM: The aim of this study is to review the rate of micrometastases and further histopathological NSLN metastases, in our unit following the introduction of OSNA in Guildford. METHODS: Data was collected prospectively from the period of introduction 01/12/2008 to 31/05/2013. All patients eligible for sentinel lymph node biopsy were offered OSNA and operations were performed by the consultant breast surgeons. Presence or absence of micro-metastases depends on the agreed cut-off point on the amplification curve. On detection of micrometastases (+) and positive but inhibited (i+) metastases, a level 1 axillary clearance (ANC) was performed and for a macrometastasis (++), a level 3 ANC was carried out. RESULTS: 66% of the patients had negative SLN (n = 672) and 34% (n = 336) had positive sentinel lymph nodes who had further axillary surgery. Of these, 45% (n = 152/336) had macrometastases, 40% (n = 136/336) had micrometastases and 15% (48/336) had positive but inhibited results. There was no difference in the patient demographics and tumour characteristics in the various positive SLN groups. In patients with micrometastases, 15% (20/136) had further positive NLSNs and a further 6% (8/136) had >4 overall positive nodes (SLN + NSLN) thus requiring adjuvant supraclavicular/chest wall radiotherapy (p < 0.05). 25% of node positive patients had further NLSN metastases (85/336) and in these patients, the ratio of positive SLN/harvested SLN (+SLN/SLN) is constant at 1:1. This shows the likelihood of further positive NSLNs if all the harvested lymph nodes are positive. This linear trend is present in both micro-and macrometastases, thus correlating with the size and number of NSLN metastases. CONCLUSION: Our study reflects the tumour burden of NSLNs based on the molecular analysis of the SLN. OSNA has the potential to accurately identify axillary micrometastases. Micro-metastases are important as some of the patients with micrometastases had overall four positive nodes [SLN + NSLN] (criteria for radiotherapy in the absence of other adverse clinicopathological features). Also, our study highlights certain factors that predict the NSLN metastases, pending validation by further prospective long-term data. This will allow accurate calculation of the axillary tumour burden, particularly in patients with micro-metastases.

A differential intra-operative molecular biological test for the detection of sentinel lymph node metastases in breast carcinoma. An extended experience from the first U.K. centre routinely offering the service in clinical practice.

INTRODUCTION: One-Step Nucleic acid Amplification (OSNA) is a molecular biological assay of cytokeratin-19 (a breast epithelial marker) mRNA. It can be employed intra-operatively for detection of lymph node metastases in breast carcinoma. Patients with positive sentinel nodes may proceed to axillary lymph node dissection (ALND) level I or higher dependent upon the OSNA quantitative result, during the same surgical procedure, avoiding a second operation and eliminating the technical difficulties possibly associated with delayed ALND. AIMS: Our Breast Unit was the first in the UK to implement this novel technique in routine practice. This study reviews our first 44-month data following introduction of OSNA "live" on whole sentinel nodes following an extensive validation study (Snook et al.).(9) METHODS: Data was collected prospectively from the period of introduction 01/12/2008 to 30/08/2012. All patients eligible for sentinel node biopsy were offered OSNA and operations were performed by five consultant breast surgeons. On detection of macro-metastasis a level II/III and for a micro-metastasis a level I ALND was performed. RESULTS: A total of 859 patients (1709 sentinel lymph nodes) were analysed. All except one were females. The majority underwent wide local excision (73.4%, n = 631) or mastectomy 25% (n = 215) and 1.6% (13) underwent SLN biopsy alone. IDC was seen in 79% (n = 680) of the patients and 53.5% (n = 460) had grade II tumours. One-third (30.8%, n = 265) had positive sentinel nodes and had further axillary surgery at the time of SLN biopsy. Of these, 47% (n = 125/265) had macro-metastases, 38% (n = 101/265) had micro-metastases and 14.7% (n = 39/265) had "positive but inhibited" results. Positive non-sentinel lymph nodes (NSLN) were seen in 35% (44/125) of those with macro-metastases; 17.8% (18/101) of the patients with micro-metastases and 10.2% (4/39) of the "positive but inhibited" group. CONCLUSION: In our series over a third of our patients had positive lymph nodes detected with OSNA allowing them to proceed directly to axillary surgery at the same operation. This technique eliminates the need for a second operation in sentinel lymph node positive patients and avoids the anxiety waiting for histological results.

Multicentre evaluation of intraoperative molecular analysis of sentinel lymph nodes in breast carcinoma.

BACKGROUND: Ideally, intraoperative sentinel lymph node (SLN) analysis in breast cancer should be automated, have high concordance with extensive histopathology, and be applicable in any hospital setting. A prospective multicentre evaluation of the one-step nucleic acid amplification (OSNA) automated molecular diagnostic system of SLN analysis was undertaken. METHODS: Intraoperative examination of SLNs from 204 patients with breast cancer was performed by OSNA at four sites in the UK. Half of each SLN was assessed by OSNA (for cytokeratin 19 mRNA) and the remaining half was paraffin embedded for intensive histological examination at ten levels. Discordant cases were reanalysed by further molecular biological techniques and by additional histological examination of all remaining nodal material to ascertain whether the discordance was due to an uneven distribution of metastases, known as tissue allocation bias (TAB). RESULTS: After exclusion of samples affected by TAB, the overall concordance rate for OSNA versus histopathology was 96.0 per cent, with a sensitivity of 91.7 per cent and a specificity of 96·9 per cent. The median time to process a single SLN was 32 (range 22-97) min, and that for two nodes 42 (30-73) min. CONCLUSION: OSNA enables accurate automated intraoperative diagnosis and can be used successfully in different UK hospitals. When the SLN is shown to be positive, the patient can undergo immediate axillary clearance under the same anaesthetic rather than having a delayed second procedure.

Current concepts in gynaecomastia.

Gynaecomastia is a common breast condition. Each case merits a careful and complete history, with thorough examination and investigations being required in selected patients with progressive disease or suspected sinister pathology. Treatment is usually indicated for any underlying cause, associated symptoms and the gynaecomastia itself. Treatment may be either medical or surgical but must be individualised. Medical treatment may be especially advocated in the symptomatic group. The indications for surgery include failure of medical treatment, intolerable side-effects of necessary drugs, malignancy, small lesions which cause significant distress and patients with large and ptotic gynaecomastia. A careful programme of counselling, pre-operatively in particular, may help to minimise litigation.

An investigation into the effect of axillary surgery on ipsilateral axillary sweating--a pleasing 'complication' or a potential treatment for hyperhidrosis?

Although there had not been complaints of excessive sweating pre-operatively, it was noticed incidentally that a large proportion of patients who had undergone axillary lymph node sampling or clearance for breast carcinoma seemed to report ipsilateral sweat loss as a pleasing 'complication'. We interviewed 65 consecutive patients who had all had axillary dissections performed by the same surgeon's technique; the interviews were held 2-102 months after their operations. In 36 cases, patients reported no change in axillary sweating (mean 35 months), whereas 29 patients reported a decrease (mean 50 months). This result was statistically significant at the 95% confidence interval (p=0.022).

Hepatic resection for breast cancer metastases.

INTRODUCTION: Hepatic resection is an established modality of treatment for colorectal cancer metastases. Resection of breast cancer liver metastases remains controversial, but has been shown to be an effective treatment in selected cases. This study reports the outcome of 8 patients with liver metastases from breast cancer. PATIENTS & METHODS: 8 patients with liver metastases from previously treated breast cancer were referred for hepatic resection between September 1996 and December 2002. Six were eligible for liver resection. The mean age was 45.8 years. The resections performed included 1 segmentectomy and 5 hemihepatectomies of which one was an extended hemihepatectomy. One patient had a repeat hepatectomy 44 months after the first resection. RESULTS: There were no postoperative deaths or major morbidity. The resectability rate was 75%. Follow-up periods range from 6 to 70 months with a median survival of 31 months following resection. There have been 2 deaths, one died of recurrence in the residual liver at 6 months and one died disease-free from a stroke. Of the remaining 4 patients, 1 has had a further liver resection at 44 months following which she is alive and 'disease-free' at 70 months. The one patient with peritoneal recurrence is alive 49 months after her liver resection with 2 patients remaining disease-free. CONCLUSION: Hepatic resection for breast cancer liver metastases is a safe procedure with low morbidity and mortality.

Testicular tumours presenting as gynaecomastia.

AIM: Gynaecomastia is the commonest benign breast condition seen in men. It is usually due to age, co-existing disease, drugs or idiopathic factors. Rarely is the cause a testicular tumour. We have assessed those men who were subsequently diagnosed as having a testicular tumour in a population of men referred to a specialist breast surgeon. METHODS: A retrospective review of 175 men who had presented with breast enlargement and/or 'lumps' over seven years (1993-2000) to a specialist breast surgeon was performed. All patients were investigated by a protocol including biochemical assessment. RESULTS: 175 men, median age 44 years (range 18-89) who presented to the breast clinic were assessed. 127 men had gynaecomastia (39 bilateral), 8 had breast cancer and 4 had testicular cancer. Of the men with testicular tumours, two had bilateral gynaecomastia; a testicular mass was palpable in two and the diagnosis confirmed on scrotal ultrasound in all four. CONCLUSION: The possibility of a testicular tumour must be considered in any male presenting with gynaecomastia. Clinical testicular examination is essential and the determination of serum tumour markers useful in the overall assessment of those presenting with 'true gynaecomastia'.

Bowel obstruction due to extrinsic compression by metastatic lobular carcinoma of the breast.

The commonest sites for breast cancer metastases are the bones, lungs, liver, pleura, adrenals and central nervous system. However, although other sites have been reported, solitary metastases to the gastrointestinal tract are extremely uncommon. Widely disseminated gastrointestinal metastases may be found in up to 20% of patients. Although only 15% of patients with breast cancer will have the lobular variety, these make up the majority of patients with solitary gastrointestinal metastases. Here we present three cases where solitary lobular breast cancer metastases have been demonstrated to be the cause of bowel obstruction. In two cases of duodenal obstruction was demonstrated and in the third colonic obstruction. In all cases a focal extrinsic compression was found.

Gynaecomastia.

Gynaecomastia is the commonest benign condition of the male breast. Management consists primarily of taking a complete history and making a thorough clinical examination. Ultrasound is recommended as the first-line imaging investigation although mammography may be added to confirm the diagnosis. The results of fine-needle aspiration cytology may be poor as an adequate yield of pathological specimens is low, and it should be reserved for suspected malignant lesions. Endocrine evaluation of gynaecomastia is rarely productive and such testing is best done selectively. Many patients can be treated simply with reassurance about the benign nature of the condition. In those patients in whom a stimulus has been identified modification of treatment may improve symptoms. Hormonal manipulation may be appropriate in younger patients, but a testicular neoplasm must be excluded. Operations should be reserved for those who fail to respond to hormones and in those with severe cosmetic deformities.

Immediate cytodiagnosis and imaging in the clinical management of discrete benign breast lesions.

Benign breast disease accounts for the majority of referrals to a specialist breast clinic. Delayed investigation prolongs patient anxiety and increases outpatient waiting lists. Few centres offer the triple test of clinical examination, fine needle aspiration cytology (FNAC) and breast imaging by mammography and/or ultrasonography at initial presentation. We have analysed the practicality of such a service during the 12 months following its introduction in our district general hospital. We studied the cohort of 178 patients who presented with a discrete breast lump which was subsequently shown to be benign. A triple test was performed in 72% of all patients. In 100 patients (56%) this was performed at initial assessment. Of these, 87 had clinically benign disease confirmed by FNAC and breast imaging and they were informed of the results within 3 h. A triple assessment during the initial consultation allows the majority of patients with discrete benign breast disease to be given immediate reassurance.

Randomized trial comparing diathermy hemorrhoidectomy with the scissor dissection Milligan-Morgan operation.

Twenty consecutive patients (12 male and 8 female) with second-degree, third-degree, or thrombosed hemorrhoids were randomly allocated to undergo either diathermy hemorrhoidectomy (n = 10) or a scissor dissection Milligan-Morgan hemorrhoidectomy (n = 10). No significant difference was found in the postoperative pain score between the groups. On a scale of 0 to 10, the mean daily pain score in the diathermy group was 4.0, and it was 4.1 in the scissor dissection group. Nor was there any significant difference in the length of inpatient stay (diathermy group, 3.5 days; scissor dissection group, 4.0 days) or in the time between the operation and the first bowel action (diathermy group, 2.0 days; scissor dissection group, 3.0 days). Diathermy hemorrhoidectomy has no significant advantage over the scissor dissection classical Milligan-Morgan hemorrhoidectomy.

Portal vein thrombosis in a complicated case of Crohn's disease.

Portal vein thrombosis is a rare complication of ulcerative colitis and is invariably fatal. This report describes a patient with severe Crohn's disease who underwent elective surgery complicated by an anastomotic disruption with faecal peritonitis. Following emergency laparotomy he developed left hypochondrial pain which was a manifestation of splenomegaly consequent upon portal vein thrombosis. Anticoagulation was successful in preventing further spread of the thrombosis as monitored by colour Doppler ultrasound. Severe active disease, surgery and sepsis have been recognized as predisposing factors for thromboembolic complications in inflammatory bowel disease and this patient was exposed to all three. It is conceivable that portal vein thromboses occur more commonly than suspected and ultrasound scanning could ascertain the prevalence if performed prospectively.

Measurement of the healing of venous ulcers.

The surface area of 99 leg ulcers was measured from a scaled photograph using a computerized ultrasonic digitizer. This was compared with the area obtained by multiplying the two maximal perpendicular diameters of each ulcer. There was an extremely good correlation between these two methods (r = 0.951). Seventy-four patients were followed up as part of a placebo-controlled double-blind study. In this study, treatment was assessed by the time taken for the ulcerated limb to heal completely. The initial ulcer size was found to be a weak predictor of subsequent ulcer healing (r = 0.49). The healing rates of individual ulcers calculated over 1 month intervals from presentation proved to be a poor predictor of the time required for complete ulcer healing (Spearman rank correlation coefficients ranged from 0.15 to 0.61). The healing curves of individual ulcers showed considerable fluctuations during the process of healing. The product of the maximal dimensions of an ulcer provides an easy and accurate method of monitoring treatment. The reduction in ulcer size within a set time interval, used in many ulcer studies, is a poor predictor of eventual ulcer healing. The percentage of ulcers completely healed within a pre-determined time interval is a better method of assessing new treatments.

Transcutaneous oxygen tensions in assessing the treatment of healed venous ulcers.

Transcutaneous oxygen tension (Ptc,O2) was assessed as an indicator of risk of reulceration in 68 limbs with healed venous ulcers. Ptc,O2 was also used to assess two methods of ulcer prophylaxis. Measurements were made over the gaiter skin, the healed ulcer and the upper arm. The results were expressed as a ratio of the lower limb readings over those taken from the arm. Patients were randomized, after the ulcer had healed, to elastic stockings and stanozolol, or elastic stockings and surgical ligation of incompetent superficial veins. Patients who declined to participate in the study were prescribed elastic stockings only. Those limbs remaining healed at 12 months had Ptc,O2 ratios remeasured. The Ptc,O2 ratios from limbs that reulcerated were not significantly lower than those from limbs remaining healed. The Ptc,O2 ratio was significantly increased in limbs treated by stanozolol and elastic stockings (P less than 0.05) and by surgery and elastic stockings (P less than 0.05). There was no significant increase in Ptc,O2 in limbs treated by elastic stockings alone. In those treated by surgery and elastic stockings, there was a significant improvement in limbs with normal deep veins (P less than 0.01), but not in limbs with post-thrombotic changes on ascending phlebography. Although these two methods of ulcer prophylaxis improve the Ptc,O2 ratio, a high ratio has not been shown to be beneficial in preventing ulcer recurrence.

Calf pump function in patients with healed venous ulcers is not improved by surgery to the communicating veins or by elastic stockings.

Calf muscle pump function was assessed in 41 limbs after venous ulcers had healed. Treatment was then randomized either to ligation of incompetent lower leg communicating veins and ablation of incompetent superficial veins combined with permanent graduated compression elastic stockings, or to graduated compression elastic stockings only. Half volume refilling time (TV1/2) and relative expelled volume (EVrel) measured on foot volume plethysmography were used to assess calf muscle pump function. This was repeated after 12 months. The initial TV1/2 and EVrel were significantly lower than for normal limbs. There was no significant improvement in TV1/2 in either treatment group (Student's t test, P = 0.78, P = 0.19). EVrel did not improve significantly in limbs treated with elastic stockings alone (P = 0.94), but there was a slight but significant improvement in EVrel in limbs treated with surgery and elastic stockings (P = 0.048); however, this was still significantly below the normal range (P less than 0.001). In limbs without phlebographic evidence of post-thrombotic changes, treated with the combination of surgery and elastic stockings, there was a significant improvement in EVrel (P = 0.035), but no improvement was found in limbs with post-thrombotic changes. This small but significant improvement in EVrel in limbs without post-thrombotic changes treated by surgery and elastic stockings may explain the reduced incidence of reulceration that has been found following surgical eradication of the superficial and communicating veins.

Changes in the apparently normal limb in unilateral venous ulceration.

Forty-seven patients with unilateral venous ulceration have been investigated to determine if any abnormalities were present in the contralateral limbs which had not had lipodermatosclerosis or ulceration. Ascending phlebography in the non-ulcerated limbs showed post-thrombotic changes in 28 per cent and incompetent lower leg communicating veins in 19 per cent. This incidence was not significantly different to the limbs with healed ulceration (45 and 23 per cent respectively, chi 2 test, P = 0.10). Half volume refilling time measured by foot volumetry suggested that 79 per cent of the non-ulcerated limbs had evidence of deep vein incompetence or incompetent lower leg communicating veins, which was again similar to the incidence in the previously ulcerated limbs (85 per cent). Transcutaneous oxygen readings, expressed as a ratio of a reading at a standard site in the gaiter region of the leg over a reading from the upper arm, were significantly lower in non-ulcerated limbs (mean 0.84 +/- 0.26 s.d.) than in a cohort of age and sex matched controls (mean 1.02 +/- 0.14, Student's t test, P less than 0.001), and significantly higher than in previously ulcerated limbs (mean 0.68 +/- 0.31, P less than 0.01). Abnormalities in venous anatomy and function have been shown, in conjunction with evidence of reduced oxygen diffusion, through the gaiter skin before overt skin changes develop.