Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence

Study Overview
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Brief Summary
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This study aimed to evaluate the effect of abdominal massage with senna-based laxative in managing overflow retentive stool incontinence in pediatrics.

Detailed Description
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Much attention has been devoted to children with overflow retentive stool incontinence (ORSI) by the pediatric surgeons, as the referral of such cases from pediatric facilities is constantly increasing. An important initial step in managing these children is the exclusion of Hirschsprung's disease starting by water-soluble contrast enema. Conservative management of ORIS is generally successful. The aim of the treatment is to achieve and maintain regular bowel movements free of symptoms Laxatives remain the mainstay of maintenance therapy of ORSI; yet, there is no standard laxative therapy despite the varieties of medication currently available. New information to these queries can be beneficial to medical staff involved in managing overflow retentive stool incontinence in pediatrics, Possibly it may add new guideline of treatment with more good result , short time and decrease the laxative dose.

Official Title
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Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics

Conditions
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Massage

Intervention / Treatment
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* Other: Abdominal massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients with ORSI according to Rome III criteria Contrast enema suggestive of fecal loading the absence of anatomic, physiologic or pathologic reason for their constipation Exclusion Criteria: radiological suspicion of Hirschsprung's disease, anorectal malformation, mechanical obstruction, failed to comply with the offered treatment (mainly if cramping abdominal pain or vomiting occurred), Required bowel surgery. spina bifida, spinal cord injury,

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First group receives senna-based laxatives . Second group managed by abdominal massage with senna-based laxatives. Evaluation of outcome of two groups as regard to continence and radiological study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: the control group<br>This group receives senna-based laxatives. | |
| Experimental: the study group<br>This group managed by abdominal massage with senna-based laxatives. | Other: Abdominal massage<br>* The patients lying in comfortable relaxed supine position and physiotherapist performed slow circular clockwise movements on the abdomen, throw tangential pushing, with digital pulp, slow and gradual pressure, with fingers inclination 45 degree. The pressure applied to the abdomen on each point for 1 min, beginning with the ascending colon, transverse colon, descending colon and sigmoid; this sequence was repeated approximately 15 min. The therapist teaches the parents this technique and asked them to apply at home 3 times / day for 15 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| starting dose | the effective starting dose at the begining of treatment. | starting dose was assessed at day 0. | 
| starting dose | the effective starting dose at the begining of treatment. | starting dose was assessed at day 180. | 
| end dose | the effective ending dose (maintenance dose) at the end of treatment. | end dose was assessed at day 0. | 
| end dose | the effective ending dose (maintenance dose) at the end of treatment. | end dose was assessed at day 180. | 
| time till not soiling | Stool soiling (encopresis) happens in children who are toilet trained. It's when they accidentally leak feces (poop) into their underwear. Constipation is one of many causes of stool soiling. Other causes include irritable bowel syndrome or when a child is fearful of the bathroom. | time till not soiling was assessed at day 0. | 
| time till not soiling | Stool soiling (encopresis) happens in children who are toilet trained. It's when they accidentally leak feces (poop) into their underwear. Constipation is one of many causes of stool soiling. Other causes include irritable bowel syndrome or when a child is fearful of the bathroom. | time till not soiling was assessed at day 180. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Laxatives, Massage