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Effective management of posthemorrhoidectomy secondary hemorrhage using rectal irrigation |
Chen H F, Wang J Y, Changchien C R, Yeh C Y, Tsai W S, Tang R P |
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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 study compared the use of rectal irrigation with examination under anaesthesia in the operating room as an initial treatment for posthaemorrhoidectomy secondary haemorrhage (PHSH). Rectal irrigation was conducted in the stoma therapy room. The patients were placed in the lithotomy position and, using a slender irrigation tube with double lumens, rectal irrigation was performed until the washout became clear. Examination under anaesthesia was conducted in the operating room, and suture ligation with or without coagulation was performed if there was an active bleeder.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients on whom elective closed haemorrhoidectomy for symptomatic haemorrhoidal disease was performed, and who then developed PHSH. Only patients fulfilling the following criteria for PHSH were included in the study:
an interval from operation to haemorrhage of more than 24 hours;
the evacuation of more than 200 mL blood or clot via the anus at one time; and
bleeding confirmed by rectal examination.
Setting The setting was secondary care. The economic study was carried out in Taiwan.
Dates to which data relate The data were collected between January 1994 and July 1996. The price year was not reported.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was undertaken prospectively on the same patient sample as that used in the effectiveness study.
Study sample No power calculations to determine the sample size were reported and no specific sample size was planned. During the study period, 4,880 consecutive patients with symptomatic haemorrhoids received a closed haemorrhoidectomy. Of these, 45 (0.9%) developed PHSH. These 45 patients were then divided into two groups according to the initial treatment, that is, rectal irrigation (n=25) or examination under anaesthesia (n=20). In the rectal irrigation group, the mean age was 44.1 (standard deviation, SD=13.4) years and 15 patients were male. In the anaesthesia group, the mean age was 37.5 (SD=9.7) years and 17 patients were male.
Study design This was a prospective cohort study that was carried out in a single centre. All the patients were followed up in the outpatient department until the wound was healed (at least one month). The mean follow-up was 9 months (range: 1 - 20). There appears to have been no loss to follow-up.
Analysis of effectiveness All the patients included in the study were accounted for at analysis. The outcomes used included the success rate of the initial treatment and patient satisfaction. Patient satisfaction with treatment was measured using a 4-point scale (very satisfied, satisfied, unsatisfied and very unsatisfied). Other complications detected at the outpatient department were also recorded. The two groups did not significantly differ in terms of gender, age, interval for the time of operation to haemorrhage, estimated amount of blood loss, systolic pressure, pulse rate, haemoglobin, or haematocrit levels at the time of diagnosis.
Effectiveness results Bleeding was effectively stopped in 22 (88%) patients undergoing rectal irrigation, but in only 12 (60%) patients undergoing examination under anaesthesia, (p=0.010).
The rectal irrigation group had a greater satisfaction rate (defined as very satisfied and satisfied) than the anaesthesia group (80% versus 10%, p<0.001).
During follow-up, one rectal irrigation patient (4%) and two anaesthesia patients (10%) developed an anal fissure, (p=0.577).
Clinical conclusions The study suggested that rectal irrigation was effective as an initial treatment for PHSH.
Measure of benefits used in the economic analysis No summary measure of benefits was derived. The study was, in effect, a cost-consequences analysis.
Direct costs The direct costs of the hospital were included in the analysis. However, it was unclear which costs were actually considered in the analysis, as the authors only reported that the cost evaluation included the total cost of hospitalisation. The source of the prices or charges used in the analysis was not given. The resource quantities and the costs were not reported separately. Discounting was unnecessary since all the costs were incurred during less than one year, and hence was not performed. The study reported the mean costs. The price year was not reported.
Statistical analysis of costs The costs were treated stochastically. A paired-sample t-test was used to compare differences between the groups. A p-value of less than 0.05 was considered statistically significant.
Indirect Costs The indirect costs were not included in the analysis.
Currency New Taiwan dollars (NT$).
Sensitivity analysis No sensitivity analysis was performed.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The cost of treating a patient was NT$1,140 (SD=2,677) with rectal irrigation and NT$7,185 (SD=1,886) when examined under anaesthesia, (p<0.001).
Synthesis of costs and benefits The costs and benefits were not combined.
Authors' conclusions The study suggested that, compared with examination under anaesthesia, rectal irrigation was cost-effective as an initial treatment for posthaemorrhoidectomy secondary haemorrhage (PHSH).
CRD COMMENTARY - Selection of comparators Examination under anaesthesia was justified as the comparator on the grounds that it represented current practice in the authors' setting. You should decide if this is a widely used health technology in your own setting.
Validity of estimate of measure of effectiveness The basis of the analysis was a prospective cohort study. Although appropriate for the study question, the potential for selection bias from this study cannot be ruled out. However, as the authors pointed out, even if randomised trials represent the ideal, they would have been difficult to implement as PHSH rarely occurs and requires prompt treatment. The study sample was representative of the study population, and the patients groups were found to be comparable in terms of age, gender distribution and underlying medical conditions. Differences between the two groups were not statistically significant, although this lack of significance might have been due to the small sample size used in the study. Appropriate statistical tests were used to test for statistically significant differences in outcomes between the two groups. There appears to have been inconsistencies in the way the authors reported their study. In the main text and abstract of their study, the authors claimed that bleeding was effectively stopped in only 12 (60%) patients in the anaesthesia group, whereas in their tables, the authors reported that effective control of PHSH was achieved in 20 (100%) patients. It is unclear whether these inconsistencies have arisen from a typographical error, or because the authors did not clearly report and explain their results.
Validity of estimate of measure of benefit The authors did not derive a summary measure of health benefit. The analysis was, in effect, a cost-consequences analysis.
Validity of estimate of costs The direct costs of the hospital were included in the analysis. It was unclear whether all the relevant unit costs were considered since the authors only reported that the total hospitalisation costs were included. The costs and the quantities were not reported separately, which will limit the generalisability of the authors' results. The mean length of stay in hospital was reported. The authors did not report where the prices and unit costs were derived from, hence the uncertain validity of the cost estimates. They did, however, perform appropriate statistical tests to test whether differences in the cost results for the two groups were statistically significant. Discounting was not performed since all the costs were incurred during less than one year. The price year was not reported, which will hamper any possible inflation exercises.
Other issues The authors made appropriate comparisons of their findings with those from other studies, the results of which were generally similar to those reported in this study. The issue of generalisability to other settings was not addressed. The authors do not appear to have presented their results selectively, although the reader should bear in mind the inconsistencies in the clinical effectiveness results presented. The authors' conclusions reflected the scope of the analysis. No limitations of the study were reported.
Implications of the study The authors reported that more aggressive treatment modalities than rectal irrigation, such as examination under surgery in the operating room, should only be performed if rectal irrigation fails to stop the haemorrhage. However, they also pointed out that the study was not conclusive, and that further randomised trials are needed.
Source of funding Supported by the National Science Council, Taiwan, Republic of China, grant number NSC89-2314B-182A-077 and NSC89-2314B-182A-079.
Bibliographic details Chen H F, Wang J Y, Changchien C R, Yeh C Y, Tsai W S, Tang R P. Effective management of posthemorrhoidectomy secondary hemorrhage using rectal irrigation. Diseases of the Colon and Rectum 2002; 45(2): 234-238 Other publications of related interest Rosen L, Sipe P, Stasik JJ, et al. Outcome of delayed haemorrhage following surgical haemorrhoidectomy. Diseases of the Colon and Rectum 1993;36:743-6.
Eu KW, Seow-Choen F, Goh HS. Comparison of emergency and elective hemorrhoidectomy. British Journal of Surgery 1994;81:308-10.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Case-Control Studies; Female; Hemorrhoids /surgery; Hospital Costs; Humans; Length of Stay /economics; Male; Operating Rooms; Patient Satisfaction; Postoperative Hemorrhage /therapy; Prospective Studies; Rectum; Therapeutic Irrigation AccessionNumber 22002000426 Date bibliographic record published 31/01/2005 Date abstract record published 31/01/2005 |
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