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

NCT04273295 | Completed

• 1 other identifier: P.T.REC/012/002277
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Massage

Keywords

Constipation; Laxatives; Massage

Outcome Measures

Primary Outcomes (6)

• starting dose

  the effective starting dose at the begining of treatment.

  starting dose was assessed at day 0.

• starting dose

  the effective starting dose at the begining of treatment.

  starting dose was assessed at day 180.

• end dose

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

  end dose was assessed at day 0.

• end dose

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

  end dose was assessed at day 180.

• 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.

• 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.

Study Arms (2)

the control group

NO INTERVENTION

This group receives senna-based laxatives.

the study group

EXPERIMENTAL

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

Other: Abdominal massage

Interventions

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.

the study group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (13)

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

  PMID: 20548277 BACKGROUND

• 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.

  PMID: 2870270 BACKGROUND

• 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.

  PMID: 26825564 BACKGROUND

• 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.

  PMID: 21382575 RESULT

• 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.

  PMID: 16678566 RESULT

• 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.

  PMID: 15289770 RESULT

• 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.

  PMID: 15479678 RESULT

• 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.

  PMID: 18534221 RESULT

• 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.

  PMID: 11986017 RESULT

• 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.

  PMID: 15730338 RESULT

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

  PMID: 21520798 RESULT

• 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.

  PMID: 15895308 RESULT

• 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.

  PMID: 19217105 RESULT

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: April 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 15, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)