Modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation for the treatment of circumferential mixed haemorrhoids: a protocol for single-blind randomised controlled study.

INTRODUCTION

This protocol designed a randomised controlled trial (RCT) to evaluate the effectiveness, safety and prognostic outcomes of modified tissue selecting technique (M-TST) combined with complete anal canal epithelial preservation (CACP) among patients with circumferential mixed haemorrhoids.

METHODS AND ANALYSIS

This study will be single-blinded, and recruit 348 patients who are admitted to the Changshu Hospital Affiliated to Nanjing University of Chinese Medicine and fulfil the inclusion criteria from January 2022 to December 2022. Patients will be randomly assigned to the treatment group and the control group in a 1:1 ratio. The statistician will be blinded for the allocation. The treatment group will receive M-TST combined with CACP (M-TST-CACP), while the control group will receive the procedure for prolapse and haemorrhoids. The two groups will receive the same preoperative and postoperative care. The primary outcome will be recurrence rate. The secondary outcomes will be operation time, intraoperative bleeding, incontinence, pain, postoperative complications (severe bleeding, perianal oedema, urinary retention, faecal urgency, skin tags and anal stenosis), prolapse, recovery time, quality of life, Haemorrhoid Severity Score, and Symptom Severity Score.

ETHICS AND DISSEMINATION

This protocol has been approved by the Clinical Ethics Committee of the Changshu Hospital Affiliated to Nanjing University of Chinese Medicine (approval no. 202102001).

TRIAL REGISTRATION NUMBER

ChiCTR2100042750.