Abstract
Introduction and hypothesis
The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function.
Methods
In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon’s perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher’s exact test, the Wilcoxon test and the Chi-squared test.
Results
Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as “more difficult than average” (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation.
Conclusions
Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon’s perception of case complexity.
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Acknowledgements
Our research was supported by the National Institutes of Health through Grant Number UL1TR001857.
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Clinical trial registration
1. Date of registration: 6 March 2013
2. Date of initial participant enrollment: 18 March 2013
3. Clinical trial identification number: NCT01805310
4. URL of registration site: https://clinicaltrials.gov/ct2/show/NCT01805310?cond=sacral+colpopexy&cntry=US&state=US%3APA&city=pittsburgh&rank=1
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Sassani, J.C., Kantartzis, K., Wu, L. et al. Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial. Int Urogynecol J 31, 1305–1313 (2020). https://doi.org/10.1007/s00192-019-04120-7
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DOI: https://doi.org/10.1007/s00192-019-04120-7