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

Primary Purpose

Massage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Massage focused on measuring Constipation, Laxatives, Massage

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • South Valley University, Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

the control group

the study group

Arm Description

This group receives senna-based laxatives.

This group managed by abdominal massage with senna-based laxatives.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2020
Last Updated
February 14, 2020
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04273295
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage
Keywords
Constipation, Laxatives, Massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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).
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the control group
Arm Type
No Intervention
Arm Description
This group receives senna-based laxatives.
Arm Title
the study group
Arm Type
Experimental
Arm Description
This group managed by abdominal massage with senna-based laxatives.
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
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 Measure Information:
Title
starting dose
Description
the effective starting dose at the begining of treatment.
Time Frame
starting dose was assessed at day 0.
Title
starting dose
Description
the effective starting dose at the begining of treatment.
Time Frame
starting dose was assessed at day 180.
Title
end dose
Description
the effective ending dose (maintenance dose) at the end of treatment.
Time Frame
end dose was assessed at day 0.
Title
end dose
Description
the effective ending dose (maintenance dose) at the end of treatment.
Time Frame
end dose was assessed at day 180.
Title
time till not soiling
Description
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 Frame
time till not soiling was assessed at day 0.
Title
time till not soiling
Description
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 Frame
time till not soiling was assessed at day 180.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A. Abo-zaid, Ph.D
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nezar A. Abo Halawa, Ph.D
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E. Ali, Ph.D
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qinā
State/Province
Qina
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20548277
Citation
Levitt MA, Pena A. Minimally invasive treatment of fecal incontinence and constipation in children. Minerva Chir. 2010 Apr;65(2):223-34.
Results Reference
background
PubMed Identifier
2870270
Citation
Turnbull GK, Lennard-Jones JE, Bartram CI. Failure of rectal expulsion as a cause of constipation: why fibre and laxatives sometimes fail. Lancet. 1986 Apr 5;1(8484):767-9. doi: 10.1016/s0140-6736(86)91783-6.
Results Reference
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PubMed Identifier
26825564
Citation
Turan N, Ast TA. The Effect of Abdominal Massage on Constipation and Quality of Life. Gastroenterol Nurs. 2016 Jan-Feb;39(1):48-59. doi: 10.1097/SGA.0000000000000202.
Results Reference
background
PubMed Identifier
21382575
Citation
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
Results Reference
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PubMed Identifier
16678566
Citation
Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
Results Reference
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PubMed Identifier
15289770
Citation
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Citation
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Citation
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Citation
Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9. doi: 10.1016/s1091-255x(01)00009-9.
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Citation
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Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence

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