Abstract
Purpose
This study was designed to evaluate the efficiency of anterior sphincteroplasty in preventing fecal incontinence relapsing in 85 female patients.
Methods
This observational study followed individuals for up to 10 years after intervention. Fecal incontinence relapse was analyzed using Generalized Linear Models and Kaplan-Meier tables. Bias due to informative censoring and missing data were assessed. Two postoperative cutoff Wexner scores (4 and 8) were used to classify individuals into continent or incontinent, and their model implications were examined.
Results
The hazard of relapsing appeared constant over time. This led to exponential time-to-relapse functions, and a linear increase of cumulative hazard over time. Predicted median relapsing time was 33 years, and overall risk 0.09 ± 0.03, when using a cutoff Wexner score of 8 (moderate), and 5 years, overall risk 0.45 ± 0.05, when using a cutoff of 4 (mild). There was a potential underestimation in parameters (bias) due to informative censoring, i.e., individual with better prognoses were more likely to drop out before relapsing compared to those with worse prognoses. Thus, true relapsing times may be longer than our current estimates.
Conclusions
The predictive model can be used in practice for individual prognosis after intervention, based on preoperative Wexner scores. The effect of anterior sphincteroplasty on fecal incontinence does not seem to deteriorate over time. A consensus Wexner cutoff is necessary to compare data and interventions.
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Acknowledgments
We acknowledge Dimitrios Vagenas (Ph.D.) and Edward Gosden (Ms.C.) for valuable comments that improved this manuscript. We also acknowledge Thomas Allison (Student of Brisbane Grammar School) for his skilled artwork displayed in the operative figures.
Ethical standards
This study has been approved by the local hospital ethical committee and has therefore been performed in accordance with ethical standards. All patients gave their informed consent prior to inclusion and prior to each phone questionnaire. All patient details that could disclose identity are omitted from this publication.
Conflict of interest
The authors declare that there are explicitly no relationships, financially or otherwise, which would lead to a conflict of interest.
Author contribution
Brendan Mcmanus—data acquisition and analysis and interpretation, drafting the article; Stephen Allison—conception and design + acquisition of data, revising and final approval; Julio Hernánchez-Sánchez—data analysis and interpretation, drafting, and revising.
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Appendix
Appendix
Assuming a constant hazard (h) over time, the time-to-relapse function can be written as S(t) = e H(t) = e −ht, where H(t) is the cumulative hazard up to year t, and S(t) is the probability of survival or feacal continence (FC). Thus, the probability of FC after AS decreases exponentially at a rate of e −h per year [18]. An estimate of h can be obtained by regressing H(t) on t, where H(t) is the KM estimate given in Table 1. The resulting equation is H(t) = 0.12 + 0.12t, so S(t) = e −(0.12+0.12t) = 0.89e−0.12t, where t = 0,…,10. The factor 0.89 in S(t) accommodates the fact that S(0) = 0.93, and not 1, i.e., there were six mild FI relapses within the first year after AS, when t = 0. When the critical postoperative WS was 8, the regression of H(t) on t rendered equation H(t) = 0.04 + 0.02t, and thus S(t) = 0.96e−0.02t.
The model in Table 3 for critical WS = 4, predicts h as a function of preoperative WS as \( h=1-{e}^{-{e}^{\eta }} \), where η = −3.55 + 0.13WS, and WS is the preoperative WS. The time-to-relapse function can be shown to be \( S(t)={e}^{-ht}=\frac{e^{t{e}^{\omega }}}{e^t} \), where ω = −0.03 × 1.14WS.
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McManus, B.P., Allison, S. & Hernánchez-Sánchez, J. Anterior sphincteroplasty for fecal incontinence: predicting incontinence relapse. Int J Colorectal Dis 30, 513–520 (2015). https://doi.org/10.1007/s00384-015-2162-5
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DOI: https://doi.org/10.1007/s00384-015-2162-5