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Completed

NCT Number: NCT04273295

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

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

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Key information

Conditions

Massage Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, 83523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Abdominal Massage

Other

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.

Primary outcomes

  1. starting dose

    Time frame: starting dose was assessed at day 0.

    the effective starting dose at the begining of treatment.

  2. starting dose

    Time frame: starting dose was assessed at day 180.

    the effective starting dose at the begining of treatment.

  3. end dose

    Time frame: end dose was assessed at day 0.

    the effective ending dose (maintenance dose) at the end of treatment.

  4. end dose

    Time frame: end dose was assessed at day 180.

    the effective ending dose (maintenance dose) at the end of treatment.

  5. time till not soiling

    Time frame: time till not soiling was assessed at day 0.

    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.

  6. time till not soiling

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 18, 2020
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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