Clinical trial NCT04273295: Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence
Official title: Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Keywords: Constipation
Laxatives
Massage
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: starting dose
timeFrame: starting dose was assessed at day 0.
measure: starting dose
timeFrame: starting dose was assessed at day 180.
measure: end dose
timeFrame: end dose was assessed at day 0.
measure: end dose
timeFrame: end dose was assessed at day 180.
measure: time till not soiling
timeFrame: time till not soiling was assessed at day 0.
measure: time till not soiling
timeFrame: time till not soiling was assessed at day 180.
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
state: Qina
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-zaid, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley University
name: Nezar A. Abo Halawa, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: South Valley University
name: Mohammed E. Ali, Ph.D
role: PRINCIPAL_INVESTIGATOR
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