CClinicalTrials.gg
CompletedNCT04273295Updated Feb 18, 2020

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

An interventional study of Abdominal massage in Massage, sponsored by South Valley University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Apr 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
4 Years to 14 Years
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Massage

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Keywords

  • Constipation
  • Laxatives
  • Massage
03

In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 216 interventional studies indexed under Fecal Incontinence.

Browse Fecal Incontinence studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

Interventions

  • OtherAbdominal 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.

06

What researchers measure

Primary outcomes

  1. starting dose

    the effective starting dose at the begining of treatment.

    Time frame: starting dose was assessed at day 0.

  2. starting dose

    the effective starting dose at the begining of treatment.

    Time frame: starting dose was assessed at day 180.

  3. end dose

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

    Time frame: end dose was assessed at day 0.

  4. end dose

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

    Time frame: end dose was assessed at day 180.

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

  6. 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 frame: time till not soiling was assessed at day 180.

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Study locations

1 site
  • South Valley University, Faculty of Physical Therapy
    Qinā, Qina 83523, Egypt
08

References and documents

Publications

  • Levitt MA, Pena A. Minimally invasive treatment of fecal incontinence and constipation in children. Minerva Chir. 2010 Apr;65(2):223-34. PubMed 20548277 ↗
  • 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. PubMed 2870270 ↗
  • 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. PubMed 26825564 ↗
  • 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. PubMed 21382575 ↗
  • 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. PubMed 16678566 ↗
  • Voskuijl WP, Heijmans J, Heijmans HS, Taminiau JA, Benninga MA. Use of Rome II criteria in childhood defecation disorders: applicability in clinical and research practice. J Pediatr. 2004 Aug;145(2):213-7. doi: 10.1016/j.jpeds.2004.04.050. PubMed 15289770 ↗
  • Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620. PubMed 15479678 ↗
  • Nurko S, Youssef NN, Sabri M, Langseder A, McGowan J, Cleveland M, Di Lorenzo C. PEG3350 in the treatment of childhood constipation: a multicenter, double-blinded, placebo-controlled trial. J Pediatr. 2008 Aug;153(2):254-61, 261.e1. doi: 10.1016/j.jpeds.2008.01.039. Epub 2008 Mar 19. PubMed 18534221 ↗
  • 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. PubMed 11986017 ↗
  • Weerapong P, Hume PA, Kolt GS. The mechanisms of massage and effects on performance, muscle recovery and injury prevention. Sports Med. 2005;35(3):235-56. doi: 10.2165/00007256-200535030-00004. PubMed 15730338 ↗
  • McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2. PubMed 21520798 ↗
  • Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available. PubMed 15895308 ↗
  • Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12. PubMed 19217105 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04273295
Lead sponsor
South Valley University
Responsible party
Mohammed E. Ali, Ph. D Candidate. (Assistant Lecturer, South Valley University) — Principal investigator
First posted
Feb 18, 2020
Start date
Apr 1, 2019
Primary completion
Oct 1, 2019
Completion
Oct 15, 2019
Last update
Feb 18, 2020

Study contacts

Nehad A. Abo-zaid, Ph.D
principal investigator · South Valley University
Nezar A. Abo Halawa, Ph.D
principal investigator · South Valley University
Mohammed E. Ali, Ph.D
principal investigator · South Valley University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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