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

BACKGROUND: Haemorrhoids are common and frequently occurring diseases in the clinical setting, and severe haemorrhoids require surgical treatment. There are various surgical methods to treat haemorrhoids, but each has advantages and disadvantages. In recent years, ultrasonic scalpels have been used in haemorrhoid surgery and have achieved good results. Ultrasonic scalpel haemorrhoidectomy is safer and more effective in the surgical treatment of grade III and IV haemorrhoids, with less intraoperative bleeding, less postoperative pain, and fewer complications than diathermic therapy, electrosurgical haemorrhoidectomy, PROXIMATE® PPH haemorrhoidal circular stapler haemorrhoidopexy (PPH), and traditional haemorrhoidectomy. In previous reports, the majority of ultrasonic scalpel haemorrhoidectomies were performed as open procedures, with only the body of the haemorrhoid removed with the ultrasonic scalpel and the wound left open for drainage and natural healing. However, we performed a preliminary experiment with 12 patients who underwent open ultrasonic scalpel haemorrhoidectomy in the early stage. The results showed that 8 patients had different degrees of postoperative bleeding, and 4 of them required a second haemostatic surgery under anaesthesia. Therefore, we modified the open ultrasonic scalpel haemorrhoidectomy procedure by removing the mucosa of the internal haemorrhoid and closing the base of the incision with figure-eight penetrating sutures and designed this study protocol to evaluate its clinical efficacy and safety. METHODS: A randomised single-blind parallel-controlled trial is proposed for this project, and patients who meet the inclusion criteria will be divided into a test group and a control group, with 39 patients in each group. The experimental group will be treated with modified ultrasonic scalpel haemorrhoidectomy, and the control group will be treated with the Milligan-Morgan operation. The effectiveness of modified ultrasonic scalpel haemorrhoidectomy for haemorrhoids will be objectively evaluated, including the incision healing time and the time for patients to return to normal activities, postoperative complications, evaluations of anal function 3 months and 6 months after surgery, an evaluation of quality of life 6 months after surgery, and an evaluation of the patient satisfaction rate 6 months after surgery. The safety assessment will consider all adverse and serious adverse events associated with the study treatment. DISCUSSION: The 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 REGISTRATION: Chinese Clinical Trial Registry (Registration ID: ChiCTR2100047229). Registered on June 11, 2021.