The efficiency and safety of modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation in circumferential mixed hemorrhoids: a randomized controlled trial.

PURPOSE

This study aimed to explore the efficiency and safety of modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation (M-TST-CACP) in the treatment of circumferential mixed hemorrhoids.

METHODS

This was a single-center, statistical analyst-blinded, randomized controlled trial (RCT). A total of 306 patients were finally included for analysis. The efficiency (efficacy, recurrence, anal smoothness, quality of life, and wound healing time) and safety (anal incontinence, pain level, anal stenosis, urinary retention, perianal edema, and postoperative bleeding) were evaluated. The statistical difference in continuous data between M-TST-CACP group and procedure for prolapse and hemorrhoids (PPH) group was compared using t-test or Mann-Whitney U test. The statistical difference in counting data between the two groups were compared using Pearson χ test. Difference within each group in different time points was evaluated using repeated-measures analysis of variance.

RESULTS

M-TST-CACP group showed a higher cure rate (6 months: 74.51% vs. 64.71%, P = 0.044), lower recurrence (6 months: 0% vs. 4.58%, P = 0.015; 12 months: 0.65% vs. 5.88%, P = 0.010), lower anal incontinence score (1 month: 1.29 ± 1.17 vs. 1.93 ± 1.33; 3 months: 1.07 ± 0.87 vs. 1.59 ± 1.01; 6 months: 0.58 ± 0.61 vs. 1.00 ± 0.90; all P < 0.001), and lower rate of anal stenosis (1 month: 0% vs. 7.84%; 3 months: 0% vs. 9.80%; both P < 0.001) than the PPH group.

CONCLUSIONS

M-TST-CACP had better efficiency and safety than the PPH, which could be a reasonable adoption for the surgeons to treat circumferential mixed hemorrhoids.