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The role of pelvic floor muscle training on low anterior resection syndrome: a multicenter randomized controlled trial
Asnong A, D' Hoore A, Van Kampen M, Wolthuis A, Van Molhem Y, Van Geluwe B, Devoogdt N, De Groef A, Guler Caamano Fajardo I, Geraerts I
Annals of Surgery 2022 Nov;276(5):761-768
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND AND OBJECTIVE: Total mesorectal excision (TME) for rectal cancer (RC) often results in significant bowel symptoms, commonly known as low anterior resection syndrome (LARS). Although pelvic floor muscle training (PFMT) is recommended in noncancer populations for treating bowel symptoms, this has been scarcely investigated in RC patients. The objective was to investigate PFMT effectiveness on LARS in patients after TME for RC. METHODS: A multicenter, single-blind prospective randomized controlled trial comparing PFMT (intervention; n = 50) versus no PFMT (control; n = 54) 1 month following TME/stoma closure was performed. The primary endpoint was the proportion of participants with an improvement in the LARS category at 4 months. Secondary outcomes were: continuous LARS scores, ColoRectal Functioning Outcome scores, Numeric Rating Scale scores, stool diary items, and Short Form 12 scores; all assessed at 1, 4, 6, and 12 months. RESULTS: The proportion of participants with an improvement in LARS category was statistically higher after PFMT compared with controls at 4 months (38.3% versus 19.6%; p = 0.0415) and 6 months (47.8% versus 21.3%; p = 0.0091), but no longer at 12 months (40.0% versus 34.9%; p = 0.3897). Following secondary outcomes were significantly lower at 4 months: LARS scores (continuous, p = 0.0496), ColoRectal Functioning Outcome scores (p = 0.0369) and frequency of bowel movements (p = 0.0277), solid stool leakage (day, p = 0.0241; night, p = 0.0496) and the number of clusters (p = 0.0369), derived from the stool diary. No significant differences were found for the Numeric Rating Scale/quality of life scores. CONCLUSIONS: PFMT for bowel symptoms after TME resulted in lower proportions and faster recovery of bowel symptoms up to 6 months after surgery/stoma closure, justifying PFMT as an early, first-line treatment option for bowel symptoms after RC.
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