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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04273295
Recruitment Status : Completed
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammed E. Ali, Ph. D Candidate., 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.

Condition or disease Intervention/treatment Phase
Massage Other: Abdominal massage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).
Primary Purpose: Treatment
Official Title: Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
No Intervention: the control group
This group receives senna-based laxatives.
Experimental: the study group
This group managed by abdominal massage with senna-based laxatives.
Other: Abdominal massage
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 Outcome Measures :
  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.



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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273295


Locations
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Egypt
South Valley University, Faculty of Physical Therapy
Qinā, Qina, Egypt, 83523
Sponsors and Collaborators
South Valley University
Investigators
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Principal Investigator: Nehad A. Abo-zaid, Ph.D South Valley University
Principal Investigator: Nezar A. Abo Halawa, Ph.D South Valley University
Principal Investigator: Mohammed E. Ali, Ph.D South Valley University
  Study Documents (Full-Text)

Documents provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Publications of Results:

Other Publications:
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Responsible Party: Mohammed E. Ali, Ph. D Candidate., Assistant Lecturer, South Valley University
ClinicalTrials.gov Identifier: NCT04273295    
Other Study ID Numbers: P.T.REC/012/002277
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed E. Ali, Ph. D Candidate., South Valley University:
Constipation
Laxatives
Massage
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases