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La anestesia local en la meatoplastia con colgajo pediculado, una tecnica eficiente en el tratamiento de la estenosis de meato [Local anaesthesia in meatoplasty with pediculated flap, an efficient technique in the treatment of meatal stenosis] |
Marchal Escalona C, Caballero Alcantara J, Padilla Leon M, Elorza Maza I |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The health interventions under study were two surgical procedures for the treatment of patients with meatal stricture: meatotomy and meatoplasty (with pedicle flap from penal skin).
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients with meatal stricture.
Setting The setting was hospital. The economic study was carried out at the Hospital Costa del Sol, Marbella, Malaga, Spain.
Dates to which data relate Data on effectiveness and resource use were gathered between May 1995 and April 1998. No price year was reported.
Source of effectiveness data The effectiveness evidence was derived from a single study.
Link between effectiveness and cost data The costing was conducted prospectively on the same group of patients as that used in the effectiveness study.
Study sample Power calculations appear not to have been performed in the preliminary phase of the study. All patients undergoing meatotomy and meatoplasty at the study hospital over the study period were enrolled: there were 11 patients in the meatoplasty group and 12 in the meatotomy group. As regards the age profile, 72.7% of patients in the meatoplasty group and 75% of those in the meatotomy group were in the age group 60-70 years.
Study design This was a prospective cohort study, carried out in a single centre, the Hospital del Sol. The same surgeon team performed all the procedures. Patients were followed for a minimum period of three months. The median length of follow-up was 11 months in the meatoplasty group and 18 months in the meatotomy group. No loss to follow-up was reported.
Analysis of effectiveness All patients included in the initial study sample were taken into account when estimating the effectiveness. The health outcomes used in the study were clinical improvement (defined as improvement of Q max in the flowmetry), immediate post-operative complications, long-term complications, and healing times. The authors stated that the two groups of patients were comparable at baseline, but only the age profile was reported.
Effectiveness results The effectiveness results were as follows:
The average values of Q max in the flowmetry were 6.07 ml/sg in the meatoplasty group and 5.8 mg/sg in the meatotoplasty group.
The final values of Q max in the flowmetry were 29.3 ml/sg in the meatoplasty group and 16.3 mg/sg in the meatotomy group. Thus the clinical improvement was higher in the meatoplasty group and this difference reached statistical significance, (p=0.02).
Healing times were 9.2 months in the meatoplasty group and 20.5 months in the meatotomy group.
There were 3 short-term complications and no long-term complications in the meatoplasty group, while there were no short-term complications and 3 complications (restenosis) in the meatotomy group.
Clinical conclusions The effectiveness analysis showed that meatoplasty was significantly more effective than meatotomy in terms of clinical efficacy and healing times.
Measure of benefits used in the economic analysis Health outcomes were left disaggregated and no summary benefit measure was used in the economic study, thus a cost-consequences analysis was conducted.
Direct costs Discounting was not relevant as costs per patient were incurred over a period of less than two years. Unit costs were reported separately from quantities of resources. The health service costs included in the economic evaluation were surgical procedure, hospital stay, urologist, outpatient visits, flowmetry, anaesthesiologist, operating room, diagnostic tests required for the surgical intervention (such as uretography, thorax X-ray, electrocardiogram, etc.). The cost/resource boundary was that of the hospital. The estimation of resource use was based on actual data derived from the patients included in the effectiveness study and was gathered from May 1995 to April 1998. Unit costs came from the hospital where the study was carried out. No price year was reported.
Statistical analysis of costs Statistical analyses of costs were not conducted.
Indirect Costs Indirect costs were not included.
Sensitivity analysis Sensitivity analyses were not carried out.
Estimated benefits used in the economic analysis Please refer to the effectiveness results reported above.
Cost results The total costs per patient were:
Pta 179,827 for meatoplasty performed in an inpatient setting and assuming three days of hospital stay;
Pta 272,707 for meatoplasty performed in an inpatient setting and assuming seven days of hospital stay;
Pta 57,525 for meatoplasty carried out in day hospital; and
Pta 39,308 for meatotomy in day hospital.
Synthesis of costs and benefits Costs and benefits were not combined as a cost-consequences study was carried out.
Authors' conclusions The authors stated that their hypotheses that meatoplasty was more effective than meatotomy and that the day hospital setting was much cheaper and safer were proven. Meatoplasty was a decisive approach as, in the long run, there was no need for reintervention, which was required with the meatotomy procedure.
CRD COMMENTARY - Selection of comparators The rationale for the choice of the comparators was clear. Meatotomy represented the standard procedure performed at the study institution before the introduction of the more recent approach of meatoplasty for the treatment of patients with meatal stricture. You, as a user of this database, should decide whether they are valid comparators in your own setting.
Validity of estimate of measure of effectiveness The effectiveness study was based on a prospective cohort design, which was appropriate for the study question. However, patients were not allocated randomly to the two procedures, thus some bias may have occurred. The authors did not comment on the comparability of the study groups, which were similar only in terms of age. The length of follow-up was reported. No patient was lost to the follow-up evaluation. The sample size was small, but the authors stated that their study represented the second largest sample published in the literature due to the low prevalence of the disease. The study sample was representative of the study population.
Validity of estimate of measure of benefit No summary benefit measure was used and the analysis was classified as a cost-consequences study, thus please refer to the commentaries reported above.
Validity of estimate of costs The perspective adopted in the study was that of the hospital and it appears that the authors included all relevant categories of costs. Unit costs and quantities of resources used were reported separately. However, the price year was not stated, thus making reflation exercises in other settings difficult. Statistical analyses of costs were not conducted. The authors considered different scenarios for inpatient and day hospital settings. Cost estimates were specific to the study setting and no sensitivity analyses were conducted.
Other issues The authors compared their findings with those of a published study based on an analysis of 32 patients. However, they did not address the issue of the generalisability of the study results to other settings, thus the external validity of the analysis was low. The study enrolled patients with meatal stricture and this was reflected in the conclusions of the analysis.
Implications of the study The study results suggest that meatoplasty under local anaesthesia should be performed for the treatment of patients with meatal stricture.
Bibliographic details Marchal Escalona C, Caballero Alcantara J, Padilla Leon M, Elorza Maza I. La anestesia local en la meatoplastia con colgajo pediculado, una tecnica eficiente en el tratamiento de la estenosis de meato. [Local anaesthesia in meatoplasty with pediculated flap, an efficient technique in the treatment of meatal stenosis] Actas Urologicas Espanolas 1999; 23(2): 140-148 Indexing Status Subject indexing assigned by NLM MeSH Aged; Anesthesia, Local; Costs and Cost Analysis; Humans; Middle Aged; Surgical Flaps; Urethral Stricture /surgery; Urologic Surgical Procedures, Male /economics /methods AccessionNumber 21999007064 Date bibliographic record published 31/10/2003 Date abstract record published 31/10/2003 |
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