MoLish
Trial question
Is modified ligation procedure superior to stapled hemorrhoidectomy in patients with symptomatic hemorrhoids?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 130
130 patients (69 female, 61 male).
Inclusion criteria: patients with symptomatic hemorrhoids.
Key exclusion criteria: acute hemorrhoidal edema; infection; bleeding; IBD, acute or chronic diarrhea; anal fistula; perianal sepsis; colorectal malignancy.
Interventions
N=64 modified ligation procedure (application of a rubber band and a silk loop to each ligation site via a proctoscope).
N=66 stapled hemorrhoidectomy (performed with a PaH32 stapler).
Primary outcome
Cure rate at 6 months
90.6%
69.7%
90.6 %
67.9 %
45.3 %
22.6 %
0.0 %
Modified ligation
procedure
Stapled
hemorrhoidectomy
Significant
increase ▲
NNT = 4
Significant increase in cure rate at 6 months (90.6% vs. 69.7%; AD 20.9%, 95% CI 7.12 to 34.68).
Secondary outcomes
Significant decrease in median hemorrhoid symptom severity score at 6 months (0 points vs. 1 points; MD -1, 95% CI -1.66 to -0.34).
Significant decrease in Wexner incontinence score at 1 month (0 points vs. 1 points; AD -1 points, 95% CI -1.94 to -0.06).
Significant decrease in median postoperative pain score at day 7 (1 point vs. 2 point; AD -1 point, 95% CI -1.79 to -0.21).
Safety outcomes
No significant differences in urinary retention, perianal haematoma.
Significant differences in cutaneous bridge edema (32.8% vs. 6.1%), anal distension (37.5% vs. 54.5%).
Conclusion
In patients with symptomatic hemorrhoids, modified ligation procedure was superior to stapled hemorrhoidectomy with respect to cure rate at 6 months.
Reference
Haibo Yang, Zhan Shi, Wei Chen et al. Modified ligation procedure for prolapsed haemorrhoids versus stapled haemorrhoidectomy for the management of symptomatic haemorrhoids (MoLish): randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac064.
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