|Stapled versus Ferguson hemorrhoidectomy: is there any evidence-based information
|Sgourakis G, Sotiropoulos G C, Dedemadi G, Radtke A, Papanikolaou I, Christofides T, Rink A D, Karaliotas C, Lang H
This review compared stapled haemorrhoidopexy with Ferguson haemorrhoidectomy and concluded that it offered comparable outcomes for a number of variables and better outcomes for operative time, pain score at 24 hours, urinary retention and wound healing. The small sample sizes, poor study quality and issues of generalisability suggest that these conclusions should be interpreted with caution.
To compare the outcomes of stapled haemorrhoidectomy (haemorrhoidopexy) versus Ferguson haemorrhoidectomy.
The Cochrane Library, MEDLINE and EMBASE were searched from 1998 to 2007 for English-language studies; search terms were reported. The reference lists of included articles were searched to identify additional articles.
Randomised controlled trials (RCTs) with at least eight weeks follow-up that compared stapled haemorrhoidopexy with Ferguson haemorrhoidectomy in patients with either third-degree, early fourth-degree or symptomatic second-degree haemorrhoids were eligible for inclusion if they reported safety or efficacy outcomes. Studies with inadequate sample sizes (not defined) were excluded.
Outcomes evaluated included pain scores, hospital stay, urinary retention, wound healing, bleeding and anal pathology; analyses were conducted on perioperative, short-term (up to four weeks) and one-year data. The mean age of patients in included studies was between 43.7 to 51 years (range 19 to 77 years). Where reported, most included patients (96 per cent) had third degree haemorrhoids.
It appeared that two reviewers independently selected studies for inclusion in the review, with disagreements resolved through consensus.
Assessment of study quality
Study quality was assessed using the 5-point Jadad scale, which assessed randomisation, blinding, withdrawals and dropouts. High-quality studies were defined as those that scored 3 or more.
It appeared that two reviewers independently assessed study validity, with any disagreements resolved through consensus.
Data for dichotomous outcomes were extracted to calculate odds ratios (OR). Means and standard deviations were extracted for continuous outcomes. Two reviewers independently extracted data; discrepancies were resolved by consensus. Where necessary, authors were contacted for further information.
Methods of synthesis
Pooled odds ratios and weighted mean differences, and their 95% CI, were calculated using a fixed-effect model. A random-effects model was used if significant heterogeneity was present. Heterogeneity was assessed using the χ2 and I2 tests. Significant heterogeneity was defined as p≤0.05. Publication bias was assessed using the Egger's test and funnel plots.
Results of the review
Five RCTs (n=926, range 40 to 596) were included in the review. The duration of follow-up was at least one year in four studies and up to eight weeks in another. One study comprised patients with grade two and three haemorrhoid's, two studies patients with grade three haemorrhoid's and two more studies with grade three and four haemorrhoid's. The quality score was 3 in four studies and 2 in one study.
Compared with Ferguson haemorrhoidectomy, stapled haemorrhoidopexy yielded statistically significant outcomes for: operative time (weighted mean difference was -19.52 minutes, 95% CI: -32.59 to -6.44; three studies); pain score at 24 hours (weighted mean difference was -2.78, 95% CI: -3.04 to -2.52; three studies); urinary retention (odds ratio was 0.42, 95% CI: 0.30 to 0.61; four studies); and wound healing (odds ratio was 5.01, 95% CI: 1.21 to 20.71; three studies). Other comparisons were not significant. Significant statistical heterogeneity was apparent for operative time (I2=99.8%). Publication bias was was absent for the majority of significant outcomes reported, but it was not reported for all outcomes.
Stapled haemorrhoidopexy offered better, or comparable, outcomes to Ferguson haemorrhoidectomy.
The review question and inclusion criteria were clear. The limited literature search was restricted to publications in English and it was unclear whether unpublished studies were sought; therefore, language bias could have been present and some studies may have been missed. All stages of the review process appeared to be conducted in duplicate, reducing the potential for error and bias. Appropriate criteria were used to assess the quality of the included studies, however, most only achieved a Jadad score of 3, and as the results of the assessment were not reported for each study it was unclear on which criteria each study failed. In addition, four of the five included studies had very small sample sizes. Suitable methods were used for the meta-analysis. Heterogeneity was assessed and found to be absent from the majority of analyses for significant outcomes. However, the authors used a p-value of 0.05 to define statistically significant heterogeneity, rather than the more commonly used conservative value of 0.10, so they were likely to have underestimated the presence of heterogeneity in the analyses. An assessment of publication bias was undertaken. It was found to be absent for the majority of significant outcomes reported, but these were not reported for all outcomes and were, therefore, of limited usefulness. The included studies contained a very high proportion of patients with third-degree haemorrhoids, therefore, the findings from this review did not appear to be generalisable to other haemorrhoid categorisations and it was unclear how generalisable the results were to clinical practice. Similarly, generalisability may be compromised due to the intervention being compared only with the Ferguson technique, given that the Milligan-Morgan technique is commonly used (particularly in Europe). Generally, this was a well-conducted review, but the findings were limited by small sample sizes, a lack of good-quality data in a clinically representative population and uncertainty over generalisability. In light of these shortcomings, the authors' conclusions should be interpreted with caution.
Implications of the review for practice and research
Practice: The authors did not state implications for practice.
Research: The authors stated that larger randomised controlled trials of longer duration were required.
Sgourakis G, Sotiropoulos G C, Dedemadi G, Radtke A, Papanikolaou I, Christofides T, Rink A D, Karaliotas C, Lang H. Stapled versus Ferguson hemorrhoidectomy: is there any evidence-based information. International Journal of Colorectal Disease 2008; 23(9): 825-832
Subject indexing assigned by NLM
Digestive System Surgical Procedures /methods; Hemorrhoids /surgery; Humans; Suture Techniques /instrumentation; Sutures; Treatment Outcome
Date bibliographic record published
Date abstract record published
This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.