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

Massage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273295
• Other study ID #: P.T.REC/012/002277
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: February 2020
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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,

Related Conditions & MeSH terms

• Fecal Incontinence
• Massage

Intervention

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.

Locations

Country	Name	City	State
Egypt	South Valley University, Faculty of Physical Therapy	Qina	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Lämås K, Lindholm L, Stenlund H, Engström 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. — View 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 — View Citation

Levitt MA, Peña A. Minimally invasive treatment of fecal incontinence and constipation in children. Minerva Chir. 2010 Apr;65(2):223-34. Review. — View Citation

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. Epub 2005 May 20. — View Citation

McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2. Review. — View 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. Review. — View Citation

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.2 — View 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. — View 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. — View 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. — View Citation

Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Mäkel 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 N — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	starting dose	the effective starting dose at the begining of treatment.	starting dose was assessed at day 0.
Primary	starting dose	the effective starting dose at the begining of treatment.	starting dose was assessed at day 180.
Primary	end dose	the effective ending dose (maintenance dose) at the end of treatment.	end dose was assessed at day 0.
Primary	end dose	the effective ending dose (maintenance dose) at the end of treatment.	end dose was assessed at day 180.
Primary	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 was assessed at day 0.
Primary	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 was assessed at day 180.