Modified ultrasound scalpel haemorrhoidectomy versus conventional haemorrhoidectomy for mixed haemorrhoids: a study protocol for a single-blind randomised controlled trial

DiscussionThe study was approved by the ethics committee. The first patient was registered on July 1 2021. The purpose of this trial will be to evaluate the clinical efficacy and safety of the modified ultrasonic scalpel haemorrhoidectomy procedure for the treatment of mixed haemorrhoids and to provide an evidence base for the clinical promotion and application of the procedure. A limitation of this study is that only the patients will be single-blinded because the researchers and the patients cannot be blinded at the same time, which may produce certain bias in the results. In addition, the sample size of this study will be small, and the test results will only represent the findings from this clinical trial. In later stages, the sample size needs to be further expanded to improve the level of evidence. Despite its limitations, we hope the present study will help provide a more optimised surgical approach in the selection of haemorrhoid surgery.Trial registrationChinese Clinical Trial Registry (Registration ID: ChiCTR2100047229). Registered on June 11, 2021.
Source: Trials - Category: Research Source Type: clinical trials