A prospective survey of patients presenting with abdominal aortic aneurysm.

OBJECTIVES: To define the presentation and management of patients presenting with abdominal aortic aneurysm (AAA) DESIGN AND SETTING: A prospective survey was carried out of all patients presenting to hospitals within the Oxford region. MATERIALS AND METHODS: Data were collected by one surgeon in each hospital. Full details were collected onto data sheets. RESULTS: One hundred and ninety patients presented, 141 electively, 46 with ruptured AAA and three with acute AAAs. In 53 patients presenting electively the aneurysm was small and surveillance started. Fifty-six patients underwent an operation, three patients died. Of 46 patients with a ruptured aneurysm 24 (52%) died. In 11 no operation was carried out and all of these patients died within 24 h. Operative mortality was 13 of 35 patients (37%). More patients with a ruptured AAA were transferred to the teaching hospital compared with a district general hospital (p < 0.05). This was reflected in a lower operative mortality in the teaching hospital. CONCLUSIONS: The presentation of AAA in this study was approximately 15 per 100,000 population. Approximately one-third of patients presenting electively had small AAAs which required surveillance. A further third underwent an operation, the remaining patients being unfit. Approximately one-quarter of patients with a ruptured aneurysm did not undergo an operation. The operative mortality was 37%.

Quality of life in patients undergoing inguinal hernia repair.

Inguinal hernia repair is one of the most common surgical procedures undertaken in the NHS. Despite this, no previous work has examined quality of life in this patient group. This study examines quality of life preoperatively and at 3 and 6 months postoperatively in 140 patients undergoing inguinal hernia repair in the context of a randomised controlled trial of laparoscopic versus open hernia repair. Surgery was undertaken on a day case basis, and quality of life was assessed using the Short Form 36 (SF36). In the initial phase of the study, 57% of those screened for suitability met the study inclusion criteria and were randomised. No significant differences were found between laparoscopic and open hernia repair in terms of quality of life at 3 and 6 months postoperatively. No difference was found between 3 and 6 month scores, suggesting that patients had already made a good recovery by 3 months. A significant improvement was found between preoperative and postoperative scores, with the greatest change arising on dimensions assessing pain, physical function, and role limitation owing to physical restriction. After standardising for age, sex, and social class, a comparison of the hernia patients to population norms for the SF36 was consistent with improvement from preoperative to postoperative assessment. This study has demonstrated the improvement in quality of life in patients undergoing elective inguinal hernia repair by experienced surgeons on a day case basis. It has also demonstrated the feasibility of assessing quality of life using generic measures in this patient group. Further work in this area is required. Ultimately, the priority given to elective inguinal hernia repair will depend on how the demonstrated benefits compare with those derived from other elective surgical procedures.

An economic evaluation of laparoscopic versus open inguinal hernia repair.

BACKGROUND: The rapid and widespread introduction of minimal access surgery has major implications for the National Health Service. It cannot be assumed that replacing an open procedure with a minimal access alternative will be cost-effective. Laparoscopic inguinal hernia repair is a procedure for which the potential economic benefits are particularly unclear. It is currently being adopted in many centres, although limited evidence on its clinical and cost-effectiveness exists. METHODS: This economic comparison of laparoscopic versus open hernia repair was undertaken on data collected on 104 patients undergoing surgery on a day case basis, in the context of a randomized controlled trial. RESULTS: The mean total health service cost of laparoscopic repair was 1074 pounds versus 489 pounds for open repair [mean difference in total health service costs 583 pounds; 95 percent confidence interval (CI) 265 pounds-904 pounds]. This difference was largely accounted for by the difference in theatre costs. Laparoscopic repair remained significantly more expensive for most but not all of the scenarios explored in the sensitivity analysis. The direction of the cost-effectiveness ratio was not sensitive to assumptions about long-term recurrence. Neither was it sensitive to halving the operating time in the laparoscopic arm of the trial. When both operating time and the costs of consumables were reduced, laparoscopic repair remained more expensive, but results for this scenario did not achieve statistical significance on this sample size. CONCLUSIONS: Laparoscopic hernia repair appears an expensive option in most plausible situations. Furthermore, many uncertainties still exist about long-term outcome after the procedure and about the conditions necessary to maximize cost-effectiveness. Large-scale randomized studies to evaluate laparoscopic hernia repair are currently under way to address these issues. We suggest that further evidence is awaited before this technology is further diffused.

Relationship between health status and postoperative return to work.

BACKGROUND: Time back to work or normal activity is often regarded as an outcome measure of interest after surgery. It has recently been used as a way of quantifying the benefits of minimal access surgery. However, the extent to which variation in time back to normal reflects differences in health status is unclear. METHODS: The relationship was examined in 140 patients recovering from inguinal hernia repair. A multi-dimensional measure of health status, the Short Form 36 (SF-36), was administered preoperatively, and at ten days and six weeks postoperatively. The relationship between scores on the SF-36 dimensions and return to normal activity was examined using correlation statistics and stepwise regression. RESULTS: Health status dimensions measuring role limitation owing to physical restriction at 10 days and 6 weeks, and role limitation owing to mental problems at ten days were associated with time to return to normal on univariate analysis. Social class was also strongly associated. Using stepwise regression these two dimensions of health status together explained 33 per cent of the variance in time to normal. Other factors unrelated to health status clearly contributed to this outcome. CONCLUSION: Time back to normal activity postoperatively is influenced by a number of factors unrelated to health status and is an unreliable proxy for it. Time to normal is therefore, not a good outcome measure for quantifying the benefits of surgical interventions. Claims currently being made to justify investment in some minimal access interventions should be interpreted in the light of this.

Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results.

OBJECTIVE: To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery. DESIGN: Randomised controlled trial. The control operation was the two layer modified Maloney darn. SETTING: Teaching hospital and district general hospital. SUBJECTS: 125 men randomised to laparoscopic or open repair of inguinal hernia. OUTCOME MEASURES: Morbidity, postoperative pain and use of analgesics, quality of life, and theatre costs. Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks postoperatively and by outpatient review at six weeks. Return to normal activity was assessed by questionnaire at three months. RESULTS: One vascular complication (2%) occurred in the group that had open repair. Seven complications (12%) including vessel injury and early recurrence arose in the group that had laparoscopic repair (difference in complication rate 10% (95% confidence interval 4% to 18%; P = 0.02). Pain scores and quality of life assessed by the short form 36 showed a significant benefit to the group that had laparoscopic repair in the early postoperative period. Return to normal activity was not significantly different between the two groups. Total theatre costs were higher in the group that had laparoscopic repair (mean cost for laparoscopic repair 850 pounds (622 pounds to 1078 pounds); mean cost for open repair 268 pounds (245 pounds to 292 pounds)). CONCLUSIONS: Because of the greater complication rate and higher theatre costs for laparoscopic repair and the patient outcome preferences expressed, the results of larger trials of clinical and cost effectiveness using recurrence as the primary outcome measure should be known before laparoscopic herniorrhaphy is widely adopted.

Sensitivity to change of health status measures in a randomized controlled trial: comparison of the COOP charts and the SF-36.

This study compared the sensitivity to change of comparable dimensions of a multi-item multi-dimensional health status measure (the SF-36) with the equivalent single item domains on the Dartmouth COOP charts. One hundred and twenty nine patients were randomized to either day case laparoscopic surgery (n = 60) or open inguinal hernia repair (n = 69). Respondents completed the SF-36 and COOP charts at baseline (prior to surgery) and at follow up at 10 days and 6 weeks. Equivalent dimensions of physical functioning, mental health/emotional condition, social activities, pain and overall condition/general health on the two questionnaires were compared. Despite slightly different pictures of change provided by the physical functioning and 'overall condition/general health' dimensions the general picture of change provided by the two instruments was similar. At 10 days, patients who underwent open surgery reported far greater levels of dysfunction than those who underwent laparoscopic surgery on both questionnaires. At 6 weeks the pain dimension of both questionnaires indicated a large improvement from baseline, whilst no other domain on either questionnaire for either group indicated such improvement. The general picture of change provided by the two measures was similar. The results suggest that both the SF-36 and the COOP charts may prove suitable for the assessment of health perception outcomes in surgical clinical trials. Differences on certain domains were caused in large measure by the nature of the questions posed. The study once again highlights the importance of checking item content to determine the suitability of any particular measure for a given study.

Rehabilitation outcome 5 years after 100 lower-limb amputations.

Received wisdom commends a policy of maximizing the ratio of below-knee to above-knee amputations in patients with end-stage arterial disease. After adoption of this policy, the long-term outcome of 100 consecutive lower-limb amputations in 96 patients was monitored by annual review for 5 years. The ratio of primary below-knee to above-knee amputations was 2:1, with 9 per cent of below-knee amputations undergoing revision to a higher level. At 2 years after amputation only 26 per cent of patients were successfully walking out of doors, while 40 per cent had died. By 5 years 67 per cent were dead and only 9 per cent continued to walk out of doors with an artificial limb, although a further 8 per cent continued to use the limb within the confines of their own homes. In a previous audit of 193 amputations performed during the 3.5 years to December 1984, stump healing was a problem in 45 per cent of primary below-knee amputations, compared with 25 per cent in the present study. Although the below- to above-knee ratio in 1984 was only 1:2, the overall rehabilitation rate, as determined by the proportion of patients able to walk at 2 years, was 34 per cent. It is concluded that increasing the proportion of below-knee amputations from one-third to two-thirds of lower-limb amputations for occlusive arterial disease does not improve effective rehabilitation rates. Received wisdom on the desirability of a high below- to above-knee ratio may be wrong.

Provision of vascular surgical services in the Oxford Region.

Vascular surgical practice across an entire health region was studied. There was a mean of 115.9 inpatient episodes and 46.9 vascular reconstructions per 100,000 population, with considerable variation between districts. Vein utilization for infrainguinal grafts was greater in the teaching hospital and few femorodistal grafts or carotid endarterectomies were carried out elsewhere; there were few tertiary referrals of elective vascular cases. Only two districts have formal arrangements for emergency vascular 'on-call'. There is marked inequality of provision of vascular surgical services across the region.

A prospective, randomized, blind comparison of three biopsy techniques in the management of patients after renal transplantation.

Although conventional histology (CH) of needle core biopsies has been accepted as the gold standard for diagnosis of renal allograft rejection, this assumption has never been tested. Fine-needle aspiration cytology (FNAC) and monoclonal antibody (panleukocyte) staining of needle core biopsies (MABS) have been suggested to be superior to CH. A total of 50 patients received a cadaveric renal transplant followed by immunosuppression with triple therapy. Biopsies were taken routinely at days 7,14,21,28, and 90, with additional biopsies taken between these times if rejection was suspected (total biopsy sessions = 219). Specimens were taken for CH, FNAC, and MABS at each biopsy session, but only the result of one technique (previously randomly allocated) was communicated back to the clinical team, using a standardized grading system. Subsequently the presence or absence of rejection was determined by retrospective analysis of the clinical and biochemical course by 4 clinicians, without reference to the biopsy result. Graft survival was not significantly different in the three groups. The sensitivities for CH, FNAC, and MABS were 75%, 59%, and 77%, respectively, while the specificities were 87%, 96%, and 80%, respectively. Inadequate samples for analysis occurred frequently with the MABS technique--and, to a lesser extent, with CH--and both techniques tended to overdiagnose rejection. FNAC most often gave an answer but did miss clinically important rejection episodes. Needle-core biopsy processed for CH remains the most reliable biopsy technique for the diagnosis of rejection of renal allografts. FNAC is a useful technique for monitoring grafts with stable function or nonfunction. MABS does provide information equivalent to CH, but, in this study, had a high incidence of inadequate samples.

Combination drug therapies for immunosuppression in transplantation.

Current combination immunosuppression protocols used worldwide include azathioprine/prednisolone, cyclosporine protocols, cyclophosphamide/steroids and FK506/steroids. The fact that many different immunosuppression protocols are currently in use, demonstrates that none is ideal. Major determinants in the choice of any protocol include graft and patient survival, side effects and cost. While most protocols may offer one year graft survival rates of 80% to 90% in renal transplantation, it is the long term results which are becoming increasingly important, but as many protocols have only been recently introduced, it may be sometime before these answers are known. While the most effective regimens include cyclosporine, long term nephrotoxicity remains a problem. Furthermore, the cost of the drug may be prohibitive in many countries worldwide. Azathioprine and low dose steroids still provide acceptable results with lesser expense and where cost and drug availability are critical, cyclophosphamide may even be introduced in place of azathioprine in living-related renal transplant recipients. The role of the newer immunosuppressive agents such as FK506 remains unclear, as the results of prospective randomised studies are not yet available. With excellent results now obtained with many different protocols, it is apparent that the choice of the most suitable immunosuppressive regimen is no longer dictated by graft survival alone.

Immunohistological analysis of renal allograft biopsies from cyclosporin-treated patients. Induced HLA-class II antigen expression does not exclude a diagnosis of cyclosporin nephrotoxicity.

Differentiation of cyclosporin nephrotoxicity from renal allograft rejection is often difficult. Induction of tubular HLA-class II antigens and elevated levels of leucocyte infiltration are associated with allograft rejection but their association with cyclosporin nephrotoxicity is unclear. In order to determine these relationships, transplant biopsies (n = 32) from patients considered to have cyclosporin nephrotoxicity, allograft rejection or stable graft function were stained with monoclonal antibodies specific for HLA-class II antigens and infiltrating leucocytes. Leucocyte infiltration was elevated during rejection but not in cyclosporin nephrotoxicity or stable graft function. While HLA-class II antigen expression was induced in 71% of the biopsies obtained during clinical rejection, no increased expression was found in the other 29%. Induced antigens were detected in five of the nine biopsies obtained in the presence of cyclosporin nephrotoxicity 90 days after transplantation. In four of these, induction was attributed to prolongation of increased class II expression following previous rejection episodes. Thus, the presence of induced class II antigens in the renal allograft does not exclude a diagnosis of cyclosporin nephrotoxicity.