Karla Alejandra Santos-Jasso1, José Luis Arredondo-García2, Jorge Maza-Vallejos3, Pablo Lezama-Del Valle4. 1. Department of General Pediatric Surgery, Instituto Nacional de Pediatría, Ciudad de México, Mexico 04530. Electronic address: santosjasso@hotmail.com. 2. Department of Medical Research, Instituto Nacional de Pediatría, Ciudad de México, Mexico 04530. 3. Department of General Pediatric Surgery, Instituto Nacional de Pediatría, Ciudad de México, Mexico 04530. 4. Department of General Pediatric Surgery, and Cochrane Center, Hospital Infantil de México Federico Gómez, Mexico.
Abstract
PURPOSE:Constipation is present in 80% of children with corrected anorectal malformations, usually associated to rectal dilation and hypomotility. Osmotic laxatives are routinely used for idiopathic constipation. Senna is a stimulant laxative that produces contractions improving colonic motility without affecting the stool consistency. We designed this trial to study the effectiveness of Senna versus polyethylene glycol for the treatment of constipation in children with anorectal malformation. METHODS: A randomized controlled crossover design clinical trial, including a washout period, was conducted, including children with corrected anorectal malformations with fecal continence and constipation. The sample size was calculated for proportions (n=28) according to available data for Senna. Effectiveness of laxative therapy was measured with a three variable construct: 1) daily bowel movement, 2) fecal soiling, 3) a "clean" abdominal x-ray. Data analysis included descriptive statistics and a Fisher's exact test for the outcome variable (effectiveness). RESULTS: The study was terminated early because the interim analysis showed a clear benefit toward Senna (p = 0.026). The sample showed a normal statistical distribution for the variables age and presence of megarectum. The maximum daily dose of Senna (sennosides A and B) was 38.7mg and 17g for polyethylene glycol. No adverse effects were identified. CONCLUSION: Therapy with Senna should be the laxative treatment of choice as part of a bowel management program in children with repaired anorectal malformations and constipation, since the stimulation of colonic propulsion waves could lead to stool evacuation without modification of its consistency which can affect fecal continence. LEVEL OF EVIDENCE: I - randomized controlled trial with adequate statistical power.
RCT Entities:
PURPOSE:Constipation is present in 80% of children with corrected anorectal malformations, usually associated to rectal dilation and hypomotility. Osmotic laxatives are routinely used for idiopathic constipation. Senna is a stimulant laxative that produces contractions improving colonic motility without affecting the stool consistency. We designed this trial to study the effectiveness of Senna versus polyethylene glycol for the treatment of constipation in children with anorectal malformation. METHODS: A randomized controlled crossover design clinical trial, including a washout period, was conducted, including children with corrected anorectal malformations with fecal continence and constipation. The sample size was calculated for proportions (n=28) according to available data for Senna. Effectiveness of laxative therapy was measured with a three variable construct: 1) daily bowel movement, 2) fecal soiling, 3) a "clean" abdominal x-ray. Data analysis included descriptive statistics and a Fisher's exact test for the outcome variable (effectiveness). RESULTS: The study was terminated early because the interim analysis showed a clear benefit toward Senna (p = 0.026). The sample showed a normal statistical distribution for the variables age and presence of megarectum. The maximum daily dose of Senna (sennosides A and B) was 38.7mg and 17g for polyethylene glycol. No adverse effects were identified. CONCLUSION: Therapy with Senna should be the laxative treatment of choice as part of a bowel management program in children with repaired anorectal malformations and constipation, since the stimulation of colonic propulsion waves could lead to stool evacuation without modification of its consistency which can affect fecal continence. LEVEL OF EVIDENCE: I - randomized controlled trial with adequate statistical power.
Authors: Marina L Reppucci; Margo M Nolan; Emily Cooper; Lea A Wehrli; Julie Schletker; Jill Ketzer; Alberto Peña; Andrea Bischoff; Luis De la Torre Journal: Pediatr Surg Int Date: 2022-09-15 Impact factor: 2.003
Authors: Mohammed M Alshehri; Cristina Quispe; Jesús Herrera-Bravo; Javad Sharifi-Rad; Sena Tutuncu; Elif Feyza Aydar; Cansu Topkaya; Zehra Mertdinc; Beraat Ozcelik; Mahima Aital; N V Anil Kumar; Natallia Lapava; Jovana Rajkovic; Andrea Ertani; Silvana Nicola; Prabhakar Semwal; Sakshi Painuli; Carlos González-Contreras; Miquel Martorell; Monica Butnariu; Iulia Cristina Bagiu; Radu Vasile Bagiu; Mrunal D Barbhai; Manoj Kumar; Sevgi Durna Daştan; Daniela Calina; William C Cho Journal: Oxid Med Cell Longev Date: 2022-02-04 Impact factor: 6.543