MassageNCT04273295

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

A study testing Abdominal massage in people with Massage, run by South Valley University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 4 to 14 years
Conditions the study is for: Massage
What is being tested?: Abdominal massage
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteEgypt
Study dates: 1 Apr 2019to 15 Oct 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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,

Trial locations and contacts

1 site in 1 country.

Egypt1 site

South Valley University, Faculty of Physical Therapy
Qina, Qena Governorate, 83523

Other trials in Egypt

About this study

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

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.

Conditions: Massage
Being tested: Abdominal massage
Keywords: Constipation, Laxatives, Massage
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Abdominal massageOther
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.

Study groups in NCT04273295
Study group	Role	What they receive
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. Receives: Other: Abdominal massage

What is being measured

The primary outcome is the main question the study is designed to answer.

starting dose
the effective starting dose at the begining of treatment.
Measured: starting dose was assessed at day 0.
starting dose
the effective starting dose at the begining of treatment.
Measured: starting dose was assessed at day 180.
end dose
the effective ending dose (maintenance dose) at the end of treatment.
Measured: end dose was assessed at day 0.
end dose
the effective ending dose (maintenance dose) at the end of treatment.
Measured: 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.
Measured: 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.
Measured: time till not soiling was assessed at day 180.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201915 Oct 2019

First posted18 Feb 2020
Study start1 Apr 2019
Primary completion1 Oct 2019
Study completion15 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for MassageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04273295
Sponsor's protocol ID: P.T.REC/012/002277
Status last verified: Feb 2020
First submitted: 14 Feb 2020
Last updated: 18 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Massage With Senna-based Laxatives Versus Senna-based Laxatives in Managing Overflow Retentive Stool Incontinence in Pediatrics
ClinicalTrials.gov ID: NCT04273295
Acronym / sponsor ID: P.T.REC/012/002277
Conditions: Massage
Keywords: Constipation, Laxatives, Massage
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: South Valley UniversityUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 15 Oct 2019 (actual)
First posted: 18 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
the control group	No intervention	–This group receives senna-based laxatives.
the study group	Experimental	Other: Abdominal massageThis group managed by abdominal massage with senna-based laxatives.

Who may qualify

Ages: 4 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Abdominal massageThe 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.	Other	the study group

Primary outcome

starting dose
Time frame: starting dose was assessed at day 0.
the effective starting dose at the begining of treatment.
starting dose
Time frame: starting dose was assessed at day 180.
the effective starting dose at the begining of treatment.
end dose
Time frame: end dose was assessed at day 0.
the effective ending dose (maintenance dose) at the end of treatment.
end dose
Time frame: end dose was assessed at day 180.
the effective ending dose (maintenance dose) at the end of treatment.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Background: PubMed 20548277Levitt MA, Pena A. Minimally invasive treatment of fecal incontinence and constipation in children. Minerva Chir. 2010 Apr;65(2):223-34.
Background: PubMed 2870270Turnbull 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.
Background: PubMed 26825564Turan 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 publication: PubMed 21382575Mugie 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 publication: PubMed 16678566Rasquin 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 publication: PubMed 15289770Voskuijl 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.
Results publication: PubMed 15479678Voskuijl 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.
Results publication: PubMed 18534221Nurko 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.
Results publication: PubMed 11986017Le 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.
Results publication: PubMed 15730338Weerapong 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.
Results publication: PubMed 21520798McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
Results publication: PubMed 15895308Liu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Abdominal massage in people with Massage, run by South Valley University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

starting dose (time frame: starting dose was assessed at day 0.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04273295, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.