Trial reportBJS open2022
Modified ligation procedure for prolapsed haemorrhoids versus stapled haemorrhoidectomy for the management of symptomatic haemorrhoids (MoLish): randomized clinical trial.
Trial report in BJS open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to compare a modified ligation procedure versus stapled haemorrhoidectomy (SH) in patients with symptomatic haemorrhoids.
methodsThis 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).
resultsOut 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).
conclusionMLPPH 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).
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