Jeong-Ki Kim1, Byeong Geon Jeon2, Yoon Suk Song1, Mi Sun Seo1, Yoon-Hye Kwon1, Ji Won Park3, Seung-Bum Ryoo1, Seung-Yong Jeong4, Kyu Joo Park1. 1. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. 2. Daejin Medical Center Bundang Jesaeng General Hospital, Seongnam, Korea. 3. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. ; Daejin Medical Center Bundang Jesaeng General Hospital, Seongnam, Korea. ; Cancer Research Institute, Seoul National University, Seoul, Korea. 4. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea. ; Cancer Research Institute, Seoul National University, Seoul, Korea. ; Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul, Korea.
Abstract
PURPOSE: This study prospectively investigated the effects of biofeedback therapy on objective anorectal function and subjective bowel function in patients after sphincter-saving surgery for rectal cancer. METHODS:Sixteen patients who underwent an ileostomy were randomized into two groups, one receiving conservative management with the Kegel maneuver and the other receiving active biofeedback before ileostomy closure. Among them, 12 patients (mean age, 57.5 years; range, 38 to 69 years; 6 patients in each group) completed the study. Conservative management included lifestyle modifications, Kegel exercises, and medication. Patients were evaluated at baseline and at 1, 3, 6, and 12 months after ileostomy closure by using anal manometry, modified Wexner Incontinence Scores (WISs), and fecal incontinence quality of life (FI-QoL) scores. RESULTS: Before the ileostomy closure, the groups did not differ in baseline clinical characteristics or resting manometric parameters. After 12 months of follow-up, the biofeedback group demonstrated a statistically significant improvement in the mean maximum squeezing pressure (from 146.3 to 178.9, P = 0.002). However, no beneficial effect on the WIS was noted for biofeedback compared to conservative management alone. Overall, the FI-QoL scores were increased significantly in both groups after ileostomy closure (P = 0.006), but did not differ significantly between the two groups. CONCLUSION: Although the biofeedback therapy group demonstrated a statistically significant improvement in the maximum squeezing pressure, significant improvements in the WISs and the FI-QoL scores over time were noted in both groups. The study was terminated early because no therapeutic benefit of biofeedback had been demonstrated.
RCT Entities:
PURPOSE: This study prospectively investigated the effects of biofeedback therapy on objective anorectal function and subjective bowel function in patients after sphincter-saving surgery for rectal cancer. METHODS: Sixteen patients who underwent an ileostomy were randomized into two groups, one receiving conservative management with the Kegel maneuver and the other receiving active biofeedback before ileostomy closure. Among them, 12 patients (mean age, 57.5 years; range, 38 to 69 years; 6 patients in each group) completed the study. Conservative management included lifestyle modifications, Kegel exercises, and medication. Patients were evaluated at baseline and at 1, 3, 6, and 12 months after ileostomy closure by using anal manometry, modified Wexner Incontinence Scores (WISs), and fecal incontinence quality of life (FI-QoL) scores. RESULTS: Before the ileostomy closure, the groups did not differ in baseline clinical characteristics or resting manometric parameters. After 12 months of follow-up, the biofeedback group demonstrated a statistically significant improvement in the mean maximum squeezing pressure (from 146.3 to 178.9, P = 0.002). However, no beneficial effect on the WIS was noted for biofeedback compared to conservative management alone. Overall, the FI-QoL scores were increased significantly in both groups after ileostomy closure (P = 0.006), but did not differ significantly between the two groups. CONCLUSION: Although the biofeedback therapy group demonstrated a statistically significant improvement in the maximum squeezing pressure, significant improvements in the WISs and the FI-QoL scores over time were noted in both groups. The study was terminated early because no therapeutic benefit of biofeedback had been demonstrated.
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