The Quality of Randomized Clinical Trials in the Field of Surgery: Studies on Laparoscopic versus Open Appendectomy as an Example


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Abstract

Background:The field of surgery undergoes rapid renewal and introduction of surgical techniques and instruments. Thus, the quality of the randomized clinical trials in this field should be evaluated. We assessed the quality of randomized trials comparing laparoscopic versus open appendectomy as a model.Method:Using MEDLINE and EMBASE, 42 first-time published randomized clinical trials in the English language met the inclusion criteria. Factors related to the methodological quality, e.g. blinding, sample size calculation and intention-to-treat analysis, were reviewed.Results:Method of random number generation was described in only 15 (36%) of the studies, i.e., it was not clear if the remaining two thirds of the studies were actually randomized or not. Although not using blocking, the trials often reported similar sample size in the intervention and control groups. Proper concealment of the allocation status was reported in almost half of the studies. None of the trials was judged to use proper double-blinding measures. Sample size calculation was present in one of five trials and half of the studies performed analysis according to intention-to-treat.Conclusions:It seems that surgical trials do not always follow the basic methodological guidelines to maintain the high quality of randomized clinical trials. Compliance with the CONSORT statement and transparency in result reporting is strongly recommended to improve the quality of randomized trials in the field of surgery.

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