A prospective randomized trial on transanal hemorrhoidal dearterialization versus stapler hemorrhoidectomy: methodological issues that need to be clarified
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We thank Leung and colleagues for their randomized clinical trial on hemorrhoid surgery . We would like to make some comments on the methodology of this study, which, in our opinion, could alter the interpretation of the results.
We believe that the sample calculation is a major drawback of this study. The sample calculation concerns postoperative pain which is the main end point, and not recurrence rate.
Pain was measured daily during the first 7 postoperative days with a linear analog pain scale of 0–10, and the median of this values was used as the main variable. However, the authors do not define “daily pain.” Is it measured based on average pain during the day or the maximum pain level of the day (probably occurring during defecation)? Besides, the authors assume a pain score difference of 1.5 between the two groups of patients to be of sufficient clinical significance to be a meaningful endpoint, with no bibliographic reference to support this possible difference and...
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Conflict of interest
Dr. Biondo is a proctor for total hemorrhoidal dearterialization with the THD device. The other authors declare that they have no conflict of interest.
This article does not contain any studies with human participants performed by any of the authors.
For this type of study, formal consent is not required.
- 1.Leung ALH, Cheung TPP, Tung K, Tsang YP, Cheung H, Lau CW et al (2017) A prospective randomized controlled trial evaluating the short-term outcomes of transanal hemorrhoidal dearterialization versus tissue-selecting technique. Tech Coloproctol. https://doi.org/10.1007/s10151-017-1669-x PubMedGoogle Scholar
- 4.Trenti L, Biondo S, Galvez A, Bravo A, Cabrera J, Kreisler E (2017) Distal Doppler-guided transanal hemorrhoidal dearterialization with mucopexy versus conventional hemorrhoidectomy for grade III and IV hemorrhoids: postoperative morbidity and long-term outcomes. Tech Coloproctol 21:337–344CrossRefPubMedGoogle Scholar