Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial.

Background: This prospective randomized controlled study was designed to evaluate the effect of biofeedback therapy (BFT) during temporary stoma period to prevent defecation dysfunction after sphincter-preserving surgery (SPS). Methods: Following SPS with temporary stoma, patients were divided according to whether (BFT group) or not (Control group) they received BFT. BFT was performed once or twice a week during the temporary stoma period. Kegel exercise were advised to all the patients. Subjective defecation symptoms were evaluated according to Cleveland Clinic Incontinence Score (CCIS) as primary outcome at 12 months postoperatively. Manometric data of five time-points were also analyzed. Results: Twenty-one patients in the BFT group and 23 patients in the control group received anorectal physiologic testing. The incidence of CCIS of more than 9 points, which is the primary end point in this study, was not statistically different between BFT group and control group (p = 1.000). The liquid stool incontinence in the BFT group showed a better tendency (p = 0.06) at 12 months post-SPS. Time-dependent serial changes in maximal sensory threshold (Max RST) was significantly different between the BFT and control groups (p = 0.048). Also, the change of mean resting pressure (MRP) tended to be more stable in the BFT group (p = 0.074). Conclusions: The BFT in the period of temporary stoma may be related to liquid stool incontinence at 12 months post-SPS and lead to stable MRP and better Max RST. Therefore, BFT during temporary stoma might be helpful for preventing and minimizing defecation dysfunction in high risk patients after SPS, NCT01661829).