Modified ligation procedure for prolapsed haemorrhoids versus stapled haemorrhoidectomy for the management of symptomatic haemorrhoids (MoLish): randomized clinical trial

BACKGROUND: The aim of this study was to compare a modified ligation procedure versus stapled haemorrhoidectomy (SH) in patients with symptomatic haemorrhoids. METHODS: This randomized trial included patients with symptomatic haemorrhoids treated in Shanghai from May 2018 to September 2021. Eligible patients were randomly 1:1 assigned the modified ligation procedure for prolapsed haemorrhoids (MLPPH) and SH groups. The primary outcome was the assessment of efficacy at 6 months after the intervention. The operating time, incidence of complications, clinical effectiveness (pain, Wexner incontinence, haemorrhoid symptom severity (HSS) scores, and 6-month cure rate) were collected, and quality-adjusted life years (QALYs) were adopted as indicator for the cost-effectiveness analysis (CEA). RESULTS: Out of 187 patients screened, 133 patients were randomized (67 for MLPPH and 66 for SH). One patient in the MLPPH group was excluded, and two patients were lost to follow-up. The mean operating time was longer in MLPPH than in SH (57.42 min versus 30.68 min; P < 0.001). The median pain score was higher in SH than in MLPPH at postoperative day 3 (P = 0.018), day 7(P = 0.013), and day 14 (P = 0.003). The median Wexner incontinence score was higher in SH than in MLPPH at postoperative month 1 (P = 0.036) and month 3 (P = 0.035), but was similar in the two groups at month 6. In addition, the median HSS score was lower in MLPPH than in SH 6 months after surgery (P = 0.003). The 6-month cure rate was higher in MLPPH than in SH (P = 0.003). CEA showed lower mean costs in MLPPH than in SH (EUR 1080.24 versus EUR 1657.97; P < 0.001) but there was no significant difference in effectiveness (P = 0.181). However, MLPPH was cost-effective (incremental cost-effectiveness ratio, −120 656.19 EUR/QALYs). CONCLUSION: MLPPH was documented as a longer but cost-effective procedure, it provided lower short-term pain, and Wexner and HSS scores. Registration number: Chinese Clinical Trial Registry ChiCTR1800015928 (http://www.chictr.org.cn/searchproj.aspx).