Y. van der Graaf

Comparison of Conventional Anterior Surgery and Laparoscopic Surgery for Inguinal-Hernia Repair

BACKGROUND Inguinal hernias can be repaired by laparoscopic techniques, which have had better results than open surgery in several small studies. METHODS We performed a randomized, multicenter trial in which 487 patients with inguinal hernias were treated by extraperitoneal laparoscopic repair and 507 patients were treated by conventional anterior repair. We recorded information about postoperative recovery and complications and examined the patients for recurrences one and six weeks, six months, and one and two years after surgery. RESULTS Six patients in the open-surgery group but none in the laparoscopic-surgery group had wound abscesses (P=0.03), and the patients in the laparoscopic-surgery group had a more rapid recovery (median time to the resumption of normal daily activity, 6 vs. 10 days; time to the return to work, 14 vs. 21 days; and time to the resumption of athletic activities, 24 vs. 36 days; P<0.001 for all comparisons). With a median follow-up of 607 days, 31 patients (6 percent) in the open-surgery group had recurrences, as compared with 17 patients (3 percent) in the laparoscopic-surgery group (P=0.05). All but three of the recurrences in the latter group were within one year after surgery and were caused by surgeon-related errors. In the open-surgery group, 15 patients had recurrences during the first year, and 16 during the second year. Follow-up was complete for 97 percent of the patients. CONCLUSIONS Patients with inguinal hernias who undergo laparoscopic repair recover more rapidly and have fewer recurrences than those who undergo open surgical repair.

Second manifestations of ARTerial disease (SMART) study: rationale and design.

The Second Manifestations of ARTerial disease (SMART) study is a single-centre prospective cohort study among patients, newly referred to the hospital with (1) clinically manifest atherosclerotic vessel disease, or (2) marked risk factors for atherosclerosis. The first objectives of the SMART study are to determine the prevalence of concomitant arterial disease at other sites, and risk factors in patients presenting with a manifestation of arterial disease or vascular risk factor and to study the incidence of future cardiovascular events and its predictors in these high-risk patients. At least 1000 patients, aged 18 to 80 years, will undergo baseline examinations, including a questionnaire on cardiovascular disease, height, weight and blood pressure measurements, blood tests for glucose, lipids, creatinine and homocysteine, urinary tests for microproteinuria, resting twelve-lead electrocardiogram, ultrasound scanning of the abdominal aorta, kidneys and the carotid arteries, measurements of common carotid intima-media thickness and arterial stiffness, and a treadmill test to assess atherosclerosis of the leg arteries. Abnormal findings are reported to the treating specialist and general practitioner with a treatment suggestion according to current practice guidelines. Recruitment and baseline examinations began in September 1996. All cohort members will be followed for clinical cardiovascular events for a minimum of three years. In the scope of secondary prevention, the study is expected to support the design of solid based screening and treatment programmes and evidence-based cardiovascular medicine to reduce morbidity and mortality, and improve quality of life, in high-risk patients.

Laparoscopic or conventional Nissen fundoplication for gastrooesophageal reflux disease: randomised clinical trial

Summary Background For the surgical treatment of gastrooesophageal reflux disease (GORD), laparoscopic Nissen fundoplication has largely replaced the open procedure. Retrospective and prospective non-randomised studies have shown similar results after laparoscopic Nissen fundoplication compared with the open procedure. Methods In a multicentre randomised trial candidates for surgical treatment of GORD were randomly assigned to either laparoscopic or open 360° Nissen fundoplication. Primary endpoints were dysphagia, recurrent GORD, and intrathoracic hernia. Secondary endpoints were effectiveness and quality of life. This planned interim analysis focuses on endpoints and complications and in hospital costs. Findings At the time of interim analysis, 11 patients in the laparoscopic group and one in the conventional group had reached a primary endpoint (p=0·01; relative risk=8·8, 95% CI 1·2–66·3). This difference was caused mainly by whether or not patients had dysphagia (seven patients in the laparoscopic group and none in the conventional group, p=0·016). Interpretation Although laparoscopic Nissen fundoplication was as effective as the open procedure in controlling reflux, the significantly higher risk of reaching a primary endpoint in the laparoscopic group led us to stop the study.

Prospective study of sentinel headache in aneurysmal subarachnoid haemorrhage.

Retrospective surveys of patients with subarachnoid haemorrhage suggest that minor episodes with sudden headache (warning leaks) may precede rupture of an aneurysm, and that early recognition and surgery might lead to improved outcome. We studied 148 patients with sudden and severe headache (possible sentinel headache) seen by 252 general practitioners in a 5-year period in the Netherlands. Subarachnoid haemorrhage was the cause in 37 patients (25%) (proven aneurysm in 21, negative angiogram in 6, no angiogram done in 6, sudden headache followed by death in 4). 103 patients had headache as the only symptom, 12 of whom proved to have subarachnoid haemorrhage (6 with a ruptured aneurysm). Previous bouts of sudden headache had occurred in only 2. Other serious neurological conditions were diagnosed in 18. In the remaining 93, no underlying cause of headache was found; follow-up over 1 year showed no subsequent subarachnoid haemorrhage or sudden death. In this cohort, acute, severe headache in general practice indicated a serious neurological disorder in 37% (95% CI 29-45%), and subarachnoid haemorrhage in 25% (18-32%). 12% (5-18%) of those with headache as the only symptom. The notion of warning leaks as a less serious variant of subarachnoid haemorrhage is not supported by this study. Early recognition of subarachnoid haemorrhage is important but will probably have only limited impact on the outcome in the general population.

Chronic idiopathic polyneuropathy presenting in middle or old age: a clinical and electrophysiological study of 75 patients.

The clinical and electrophysiological features were prospectively studied of 75 patients (46 men and 29 women) with chronic polyneuropathy presenting in middle or old age in whom a diagnosis could not be made even after extensive evaluation and a follow up of six months. The mean age at the onset of symptoms was 56.5 years. The clinical features of chronic idiopathic polyneuropathy are heterogeneous. On clinical grounds 44 patients had a sensorimotor, 29 patients a sensory, and two patients a motor polyneuropathy. The overall clinical course in chronic idiopathic polyneuropathy was slowly progressive. None of the patients became severely disabled. Electrophysiological and nerve biopsy studies were compatible with an axonal polyneuropathy. Antibodies against myelin associated glycoprotein, gangliosides, and sulphatides were assessed in 70 patients and found to be negative.

Quality of life after treatment of unruptured intracranial aneurysms by neurosurgical clipping or by embolisation with coils. A prospective, observational study.

Background: Relatively high rates of complications occur after operation for unruptured intracranial aneurysms. Published data on endovascular treatment suggest lower rates of complications. We measured the impact of treatment of unruptured aneurysms by clipping or coiling on functional health, quality of life, and the level of anxiety and depression. Methods: In three centres, we prospectively collected data on patients with an unruptured aneurysm who were treated by clipping or coiling. Treatment assignment was left to the discretion of the treating physicians. Before, 3 and 12 months after treatment, we used standardised questionnaires to assess functional health (Rankin Scale score), quality of life (SF-36, EuroQol), and the level of anxiety and depression (Hospital Anxiety and Depression Scale). Results: Nineteen patients were treated by coiling and 32 by clipping. In the surgical group, 4 patients (12%) had a permanent complication; 36 of all 37 aneurysms (97%) were successfully clipped. Three months after operation, quality of life was worse than before operation; 12 months after operation, it had improved but had not completely returned to baseline levels. Scores for depression were higher than in the general population. In the endovascular group, no complications with permanent deficits occurred; 16 of 19 aneurysms (84%) were occluded by more than 90%. One patient died from rupture of the previously coiled aneurysm. In the others, quality of life after 3 months and after 1 year was similar to that before treatment. Conclusions: In the short term, operation of patients with an unruptured aneurysm has a considerable impact on functional health and quality of life. After 1 year, recovery occurs but it is incomplete. Coil embolisation does not affect functional health and quality of life.

Intermittent cyclophosphamide and prednisone treatment of polyneuropathy associated with monoclonal gammopathy of undetermined significance

In an open prospective study, we analyzed the effect of cyclophosphamide (300 mg/m2 body surface daily for 4 days) combined with prednisone (40 mg/m2 body surface daily for 5 days) at 4-week intervals during 6 months in 16 patients with polyneuropathy associated with monoclonal gammopathy of undetermined significance (MGUS). Eleven patients had an IgM-MGUS and five an IgG-MGUS. During a follow-up period of 3 years, eight patients had improvement and six patients stabilized, based on quantitative neurologic examination, the Rankin disability scale, and electrophysiologic studies. These 14 patients had neuropathy with demyelinating and axonal features. One patient with a purely axonal neuropathy had deterioration despite therapy. One other patient developed severe leukopenia as side effect of cyclophosphamide, necessitating withdrawal of treatment. A difference in response was not present in patients with IgM- or IgG-MGUS, nor in patients with or without autoantibodies against myelin-associated glycoprotein. Nine patients had a bone marrow biopsy before and 1 year after treatment. In eight patients, the monoclonal lymphoid IgM or plasma cell IgG infiltration decreased, while in four the monoclonality disappeared after treatment. In the patient who had neurologic deterioration, repeated bone marrow biopsy showed deposits of amyloid. In conclusion, short-term treatment with intermittent cyclophosphamide and prednisone may have a long-term favorable effect in patients with demyelinating polyneuropathy associated with MGUS. NEUROLOGY 1996;47: 1227-1233

Risk of strut fracture of Björk-Shiley valves

The incidence of and factors that predispose to outlet strut fracture of Björk-Shiley heart valves are still not known. To obtain such information a retrospective cohort study was conducted on all 2303 patients in the Netherlands with a 60 degrees convexo-concave (60 degrees CC) or a 70 degrees convexo-concave (70 degrees CC) Björk-Shiley heart valve. Patients have been followed-up for a mean of 6.6 years (range 1-4271 days). 42 cases of mechanical failure due to outlet strut fracture have been recorded-6 of the 7 patients with fracture of the aortic valve died, as did 18 of the 35 patients with fracture of the mitral valve. Multivariate analysis identified wide opening angle (70 degrees), large valve size (greater than or equal to 29 mm diameter), and young age (less than 50 years) as risk factors for outlet strut fracture. For large 70 degrees CC mitral valves the cumulative risk of outlet strut fracture after 8 years was 17.4% (95% CI 9.1-31.6). Unlike previous findings, this excessive risk applied to late as well as to early batches of valves. In patients with a large 60 degrees CC mitral valve the cumulative risk after 8 years was 4.2% (95% CI 2.7-6.5). The incidence rate of outlet strut fracture in 60 degrees CC and 70 degrees CC valves (aortic and mitral) was constant over time. Overall survival since implantation was better for patients with 60 degrees CC prostheses than for those with 70 degrees CC prostheses; the adjusted hazard ratio for mortality for patients receiving a 70 degrees CC prosthesis was 1.5 (95% CI 1.1-2.0). Together with the low (24%) necropsy rate, this ratio suggests that the reported incidence of strut fracture for the 70 degrees CC valves is an underestimate. The data indicate that prophylactic replacement of 60 degrees CC and 70 degrees CC valves is advisable for selected groups of patients. Since the case-fatality rate is 50% for emergency replacement of faulty valves, patients suspected of Björk-Shiley heart-valve failure should be referred without delay to a cardiothoracic centre.

Screening for asymptomatic internal carotid artery stenosis and aneurysm of the abdominal aorta: comparing the yield between patients with manifest atherosclerosis and patients with risk factors for atherosclerosis only.

OBJECTIVE The purpose of this study was to investigate whether screening for internal carotid artery stenosis (ICAS) and aneurysm of the abdominal aorta (AAA) is indicated in patients with either manifest atherosclerotic disease or with only risk factors for atherosclerosis. STUDY DESIGN Data were obtained for 2274 patients enrolled in the SMART study, an ongoing single-center, prospective cohort study of patients referred to our vascular center with manifest atherosclerotic disease (peripheral atherosclerotic disease [PAD]; transient ischemic attack [TIA], stroke, or ICAS; AAA; angina pectoris; or myocardial infarction [MI]) or with only risk factors for atherosclerosis (diabetes mellitus, hypertension, hyperlipidemia). The presence of ICAS or AAA was determined with duplex scanning and ultrasonography. RESULTS The prevalence of ICAS 70% or greater is low in patients with risk factors for atherosclerosis only (1.8%-2.3%), intermediate in patients with angina pectoris or MI (3.1%), and highest in patients with PAD (12.5%) or AAA (8.8%). The prevalence of AAA 3 cm or larger is low in patients with risk factors for atherosclerosis only (0.4-1.6%), intermediate in patients with angina pectoris or MI (2.6%), and highest in patients with PAD (6.5%) or TIA, stroke, or ICAS (6.5%). The prevalence of AAA larger than 5 cm is low in all of the considered patient groups. The yield of screening can be optimized through selection on the basis of simple patient characteristics. In patients with PAD, selecting those with advanced age (>54 years) increased the prevalence of ICAS to 21.8%. Selecting patients with lower diastolic blood pressure (<83 mm Hg) increased the prevalence of ICAS to 17.9%. In patients with both advanced age and lower diastolic blood pressure, the prevalence of ICAS increased to 34.7%. Selecting patients with advanced age increased the prevalence of AAA 3 cm or larger to 9.6%. In patients with TIA, stroke, or ICAS, selecting those with advanced age increased the prevalence of AAA 3 cm or larger to 8.2%. Selecting patients with taller stature (>169 cm) increased the prevalence of AAA 3 cm or larger to 9.3%. In patients with advanced age and taller stature, the prevalence of AAA 3 cm or larger increased to 13.1%. CONCLUSIONS Screening for ICAS should be limited to patients referred with PAD or AAA, especially those with advanced age or with low diastolic blood pressure. Screening for AAA should be limited to patients referred with PAD or with TIA, stroke, or ICAS, particularly those with advanced age or tall stature. In patients referred with angina pectoris or MI and those referred with only risk factors for atherosclerosis, screening cannot be endorsed.

Psychosocial intervention following suicide attempt: a systematic review of treatment interventions.

Repeated suicide attempts are a common problem. However, few randomized controlled studies on the treatment of suicide attempters have been described. Although some of these studies showed beneficial effects on measures of well‐being, none of them demonstrated lasting positive effects on repeated suicidal behaviour. In an attempt to analyse the results obtained, a systematic review of randomized controlled trials of interventions for suicide attempters is presented. The literature was gathered by means of a CD‐ROM literature reference search (MEDLINE/PSYCLIT). Subsequently, information on study design and treatment efficacy was abstracted. Studies that were homogeneous with regard to therapeutic principles were reviewed accordingly, and pooled analyses were performed. Meta‐analyses accounted for inter‐study variance (random‐effects model) to estimate a commmon‐effect measure (relative risk). Systematic review of the data showed considerable differences in both study design and therapeutic protocols. In view of these differences, a single pooled analysis of all studies appeared to be unfeasible. A pooled analysis of studies that focus on psychiatric management of poor compliance showed no significant effect on the repetition of suicide attempts. Similarly, studies of psychosocial crisis intervention, as well as studies of guaranteed in‐patient shelter in cases of emergency, did not show a significant reduction in repeated suicide attempts. However, the pooled results of four studies on cognitive‐behavioural therapies showed a significant preventive effect on repeated suicide attempts. At present, only the cognitive‐behavioural approach appears to have a beneficial effect on repeated suicide attempts. However, because of methodological variability, the results obtained may be too optimistic. Additional research is required to establish the merits of this type of intervention.