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

Not Applicable

Completed

• Conditions: Massage
• Interventions: Other: Abdominal massage

• Registration Number: NCT04273295
• Lead Sponsor: South Valley University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-15
• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Last Update Submitted: 2020-02-14
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the study group	Abdominal massage	This group managed by abdominal massage with senna-based laxatives.

Primary Outcome Measures

Name	Time	Method
starting dose	starting dose was assessed at day 180.	the effective starting dose at the begining of treatment.
end dose	end dose was assessed at day 180.	the effective ending dose (maintenance dose) at the end of treatment.
time till not soiling	time till not soiling was assessed at day 180.	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.

Trial Locations

Locations (1)

South Valley University, Faculty of Physical Therapy; 🇪🇬 Qinā, Qina, Egypt